March 9,2010

18:04
Green CDA is a simplification project. It is a worthwhile effort to simplify working with CDA.
Categories: All , News and Views
18:03

HERtalk by Inga

From: Sioux Supporter “Re: Janet Dillione. I can confirm that Janet Dillione has resigned from Siemens. No announcement of new role or firm, but the announcement was made Friday.” Still unconfirmed, though a few readers have sent note with similar messages.

isoft

From: Big Mouth “Re: iSOFT. iSoft loses another senior executive from it’s flagship business unit. Just confirmed from internal source that Keith Kirtland, UK&I Commercial and Sales Director resigned earlier this month. This is the 4th sales director in as many years and is expected to have a destabilising effect on both the Wales Lab deal and overall sales in the UK for this troubled NPfIT supplier. In February,  iSOFT reported significant drops in both revenue and profit.  This resignation will certainly impact 2nd half results.”

From: Beauty “Re: Press Releases. To Beastly – I see you are putting the spin on the negative. Any which way you slice it – too many press releases = too little bang…leaving out ‘for the buck’ cuz we know you are still pulling down the bucks. Too much noise at HIMSS…and those who would be interested are too busy ‘doing’ HIMSS. As for me – I deliberately launched product before HIMSS…with press release…specifically to avoid the noise and being one of the 100 needles lost in the haystack. Hmmm – opinion of the those who are in the business of press releases…or those of us targeted by the press releases?  Listen to your audience. Let’s have a HIStalk vote on this one!” Personally I am just happy that it took less than a week for me to finally weed through all those releases.

From: William Tell “DoD and VA disconnect. Nice to know CPOE and electronic records are going to solve everything . . . as if.”

promise

From: Curious “Re: Promise Healthcare. I am curious about your opinion of them.” Alas, I have no opinion since I know nothing about them. In the absence of the ever-wise Mr. H, perhaps readers can weigh in.

From: Emily Dickinson “Re: Medical Manager execs guilty. Two former executives of Medical Manager Health Systems Inc. have been convicted of federal securities fraud after a two-month trial in U.S. District Court in Charleston, SC.” The company’s former VP and COO John P. Sessions and former president John H. Kang were found guilty of conspiracy to commit mail, wire and securities fraud for their part in a scheme to inflate Medical Manager’s earnings by more than $16.8 million between 1997 and 2003. Sentencing will occur at a later date.

From: Mr. H “Re: Charles McCall heading to prison.That news made my day.” Really? I get one email from Mr. H in four days, and this is all he has to say. What’s up with that?

Quest Diagnostics and Surescripts team up to form an integrated service that combines lab and prescription information available to connected physicians. I suppose that means that if my grandmother in Washington goes to a doctor in Florida, the Florida doctor might be able to access Grannie’s lab and prescription data. Now we are getting somewhere.

Surescripts, by the way, reports that e-prescribing rates tripled from 2007 to 2009, with an estimated 18% of all eligible prescriptions now being sent electronically. The number of prescribers routing prescriptions doubled from 2008 to 2009, and now includes 25% of all office-based physicians.

huntington

Huntington Memorial Hospital (CA) plans to offer HuntingtonRx, a branded version of Allscripts stand-alone e-prescribing solution, to its 1,000 affiliated physicians.

Five hospitals select Summit Healthcare as their sole integration partner to assist with migrations from current Meditech platforms to Meditech 5.0.

Annapolis Pediatrics selects Sage Intergy suite to automate its clinical and financial operations. Annapolis Pediatrics is a four-location, 21 provider group.

Trinity Health (MI) deploys Medicity’s Novo Grid solution, establishing an HIE between almost 1,000 affiliated physicians. The headline of the press release claims this first stage took “9-1/2 weeks,” which happens to be the same amount of time it took Kim Basinger’s Elizabeth to walk away from Mickey Rourke’s John.

Sisters of St. Francis Health Services (IN) select Epic for its 13-hospital system.

Northwest Hospital & Medical Center (WA) contracts with dbMotion to create an interoperable patient record for both in-hospital and ambulatory care providers.

UPMC introduces an EHR application that runs on a BlackBerry smartphone. The program leverages the interoperability platform created by dbMotion and provides a single view of key patient data from multiple information systems.

Henry Schein launches ConnectHealth, which partners companies in the EHR, medical device and computer services sectors. Specifically it sounds as if the new program leverages Henry Schein’s partnerships with several vendors to implement EMR in physician offices. Partner vendors include Allscripts, Midmark, Welch Allyn, Siemens, Dell, and Medline.

barcelona

The nice folks at Bridgehead Software have invited me to visit their booth at the World of Health IT event in Barcelona, March 15-18. Bummer that I have a manicure scheduled during that time so I will have to miss the event. If you are attending, visit the Bridgehead team at Stand #841 and sign up to win an iPad.

Speaking of Spain, Gestion Sanitaria de Mallorca in Palma selects Orion Health technology to serve as the background for its EHR. The EHR solution will be the first for community care in Spain.

We have a new interview on HIStalk Practice with Dr. Joel Feinman of Valley Medical Group in Massachusetts. He’s an EMR proponent on many levels, but especially in terms of providing patient care: “I don’t see how you can do that anymore without some kind of electronic system that actually works.” Check it out and sign up for e-mail updates while you are there.

Today I joined a conference call with the wonderful sponsors of last weeks HIStalk reception. After accounting for walk-ins and a few no shows, total attendance was about 430, making it our biggest bash ever. Thanks again to Encore, Evolvent, and Symantec for making it such a great event.

General Dynamics Information Technology hires Raymond Sullivan to serve as VP of HIT Solutions, tasked with business development for the federal government and commercial health organizations. Sullivan was previously executive director of the VA’s Office of Information and Technology.

Hospital nurses estimate they spend a quarter of their 12-hour shift on indirect patient care. Wow. While not providing direct patient care, nurses are working on regulatory requirements, handling lots of paperwork, and securing needed equipment and supplies. Solutions recommended by surveyed nurses include more ancillary staff support, better hospital-wide communications technology, and reductions in redundant regulatory requirements.

anne arundel

Anne Arundel Medical Center (MD) implements Corepoint Integration Engine to facilitate a migration to Epic’s HIS and improve clinical data exchange with community physicians and patients.

In what could be the greatest news of the decade, a report in the Archives of Internal Medicine finds that normal-weight women who drink a light to moderate amount of alcohol appear to gain less weight and have a lower risk of becoming overweight and obese than non-drinkers. On that note, I’m off to find a cocktail.

inga

E-mail Inga.

Source: HISTalk
17:28

Today, WebMD announced the launch of its new social media initiative, WebMD Exchange.  It’s a dud.

Being WebMD, the leading online consumer health, it is a bit surprising that they are so late to the party as there are now quite a number of health-related social media sites such as one of Chilmark’s favorites, the focused Patients Like Me or the more broad ranging site MedHelp.  Thus, with this announcement one would think that WebMD would have studied the other sites, learned what works and what does not and provide a compelling site.

So much for assuming.

Went to the site today to check it out, here are the quick pluses and minuses:

In the plus column the site has…

1) A number of exchanges to address a wide range of conditions.

2) Some of these exchanges focus on care giver issues, such as parents of children with depression.

3) Registered members can create their own exchanges.

4) For diseases with medications, a list is automatically generated of the relative popularity and use of various medications with member reviews (e.g. side effects, overall effectiveness, etc.).

In the minus column the site…

1) Is cluttered and noisy, hard to determine what to read that is pertinent and what is fluff.  Seems to be an amalgamation of everything not to do in a social community site, let alone one addressing health & wellness.

2) Much of that noise comes from ads. Now ads are not a bad thing if they pertain to the disease/condition within that exchange.  Finding a postmenopausal ad in a section on cancer or a Charmin toilet paper ad in childhood depression?  Please, WebMD, the technology is there to do a better job than this for your members.

3) Lots of click-thrus to see pretty much everything.  Since online ad pricing algorithms often have a site retention/click metric, WebMD is purposely making it more difficult to get at content to maintain its ad pricing power – not nice WebMD.

4) Very little if any policing seems to be occurring leading to the creation of many communities (exchanges in WebMD parlance) that are of little value or just plan silly.  A favorite in the Anxiety-Panic category was the Exchange, OMG Zombies.

5) For some conditions there can be several exchanges. Fne, nice to have choice but which one is truly a vibrant exchange.  Well, that answer is not apparent until you click-thru (more clicks, more ads) to determine if an exchange is vibrant.  Royal pain in the a**.

Bottomline:

WebMD’s attempt at using social media within the context of these exchanges is late to market and one of the poorest executions of such that we have seen.  Granted, maybe we had high expectations for WebMD as it truly is the 800lb gorilla in this market. Sadly, those expectations were not even close to being met.

Hey WebMD, why not take a smidgen of that $800M in cash and investments you have hoarded up and actually do this right.  It will be an extremely modest investment that could pay off handsomely rather than this half-baked attempt which is frankly embarrassing and will likely fail.


Categories: All , MedTech and Devices
16:43

The Office of the National Coordinator for Health Information Technology has withdrawn the proposed rule establishing a certification program for electronic health records software and replaced it with a corrected version.
ONC on March 2 placed the proposed rule on the Federal Register's public inspection desk, making it available for viewing before official publication. That version, FR Doc. 2010-04665, has been replaced with version FR Doc. 2010-4991, which will be officially published in the Federal Register on March 10. Publication will start the clock for public comment periods for the proposed temporary and permanent EHR testing and certification programs.


16:02
DellAs government and healthcare leaders invest billions of dollars in healthcare information technologies (IT) to improve the accessibility, affordability and quality of healthcare for their citizens, hospital datacenters may not be ready for the demand that more patients and digital information will create, according to a survey of hospital IT executives at small and medium hospitals in the U.S., U.K., Canada, China, France and Germany conducted by the HIMSS Analytics, sponsored by Dell.


16:02
DellAs government and healthcare leaders invest billions of dollars in healthcare information technologies (IT) to improve the accessibility, affordability and quality of healthcare for their citizens, hospital datacenters may not be ready for the demand that more patients and digital information will create, according to a survey of hospital IT executives at small and medium hospitals in the U.S., U.K., Canada, China, France and Germany conducted by the HIMSS Analytics, sponsored by Dell.


16:01
System CSystem C has been named one of the top 100 companies to work for in the UK. The software and services company won a place in the 2010 Sunday Times Best 100 Companies to Work For survey, published in the Sunday Times this weekend.


16:01
System CSystem C has been named one of the top 100 companies to work for in the UK. The software and services company won a place in the 2010 Sunday Times Best 100 Companies to Work For survey, published in the Sunday Times this weekend.


16:00
Agfa HealthCareAgfa HealthCare, the leading provider of diagnostic imaging and healthcare IT solutions, has installed the United Kingdom's first IMPAX 6.4 Picture Archiving and Communications System at the Hospital of St John & St Elizabeth in London.


16:00
Agfa HealthCareAgfa HealthCare, the leading provider of diagnostic imaging and healthcare IT solutions, has installed the United Kingdom's first IMPAX 6.4 Picture Archiving and Communications System at the Hospital of St John & St Elizabeth in London.


15:48
I usually don’t use this space to promote local/regional events.  After all, HealthBlog has a worldwide audience of readers.  However, I’m making an exception because the event I want to promote takes place on home turf and it was after all...(read more)
Source: HealthBlog
Categories: All , MedTech and Devices
15:00
Salar's TeamNotes is an in-patient documentation system designed to sync with tablet PCs and eliminate paper-based records moving between departments and providers in a health-care setting. According to Salar, TeamNotes can be embedded into an existing EMR and customized to create patient demographic information and barcodes, and also address CPT coding, laboratory results and general workflow needs. It's part of a suite of Salar documentation and workflow products that also includes TeamRelay -- lists that are pre-populated, in real time, with patient data and task lists -- and TAP Charge Captrue, a billing application that syncs to TeamNotes. Salar has grown an app developer community around TeamNotes by making it available as a .NET component and as a Web-based Active X control.

















Salar is realizing an exciting vision that began over ten years ago. We have transformed traditional paper clinical documentation into electronic “smart” paper. Our products deliver all the convenience, speed, and information-sharing that integrated systems and wireless access can provide!

Salar's unique approach allows physicians to replicate their familiar paper-driven documentation into electronic format.  Physicians design their owndocumentation forms and then can drive multiple value-added activities from it like:
With Salar, Physicians can continue practicing just as they do today and are not forced to change their style of work.
Hospitals identify missing or incomplete documentation in time to make appropriate clarifications.
Salar has applied technology and expertise to improve healthcare quality and efficiency with the best clinical documentation and charge capture tools on the market today!


14:32
The views and opinions expressed in this blog are mine personally, and are not necessarily representative of Texas Health Resources (THR) or its subsidiaries. 1997. The reverberating rave music generated a hip vibe. Cameras flashed as bright lights drew...(read more)
14:19
8 March 2010 - Anglo-Swedish pharma major AstraZeneca (LON: AZN) (STO: AZN) said today its tablet cancer drug Recentin did not prove equal to injectable rival treatment Avastin by Swiss Roche AG (VTX: ROG) in a head-to-head Phase III trial.

The so-called Horizon III study did not meet the primary endpoint to prove non-inferiority of Recentin as a treatment for metastatic colorectal cancer (mCRC) in combination with chemotherapy.

Both Recentin (cediranib) and Avastin (bevacizumab) are designed to starve tumours by stopping them from building blood vessels, a process called anti-angiogenesis.

Although AstraZeneca was aware of the risks with challenging Avastin, the company is disappointed with the results.

Nevertheless, the pharma major maintained its financial guidance for 2010.

Horizon III is one of two pivotal studies of Recentin in mCRC. Data from the Horizon II trial, which is testing Recentin combined with chemotherapy against chemotherapy alone, is expected in the next months.

Based on the results from these two studies, AstraZeneca will decide whether it will apply for marketing approval of Recentin as a treatment for mCRC.

Recentin is also being tested in recurrent glioblastoma multiforme (GBM) brain tumours.


14:17

The Third Eye Retroscope from Avantis Medical Systems (Sunnyvale, CA) is getting some good reviews in two studies just published in Gastrointestinal Endoscopy. The device works in conjunction with a standard colonoscope to look behind, kind of like a rear view mirror in a car. And as designed, this device is proving valuable in spotting polyps that would otherwise have gone unnoticed.

From an Avantis Medical press release:

The first study was led by Dr. Jerome D. Waye, Clinical Professor of Medicine at Mount Sinai School of Medicine, New York, NY. Titled “A Retrograde-Viewing Device Improves Detection of Adenomas in the Colon: A Prospective Efficacy Evaluation,” the study involved 14 investigators and 249 patients at 8 medical centers in the U.S.1 The investigators found that the Third Eye improved detection and removal of polyps by 13.2% compared to the colonoscope alone. For adenomas, the polyps that are most likely to become cancers over time, the additional detection rate with the Third Eye was 11.0% for lesions of all sizes. For medium-size adenomas (at least 6 mm in diameter), the additional detection rate with the Third Eye was 25.0%, and for large adenomas (at least 10 mm), they found 33.3% more with the Third Eye. Thus, the Third Eye not only allowed for identification of more polyps, but its greatest yield was in the detection of larger adenomas, which are further along in the progression to cancer.

The second study was led by Dr. Daniel C. DeMarco, Director of Endoscopy at Baylor University Medical Center, Dallas, TX. Titled “Impact of Experience with a Retrograde-Viewing Device on Adenoma Detection Rates and Withdrawal Times during Colonoscopy: the Third Eye Retroscope Study Group,” the study involved 298 patients at 9 U.S. sites, and was conducted by 17 investigators who had not previously used the device.2

Overall, beginning with the very first time they used the device, the Third Eye allowed the investigators to find 16.0% more adenomas in addition to those they were able to find with the colonoscope alone. However, after each investigator had gained some experience with the device by performing 15 procedures, their average additional adenoma detection rate with the Third Eye compared to the colonoscope alone was 25.0%. Again considering their overall results from start to finish, the endoscopists found a higher proportion of larger pre-cancerous adenomas that were hidden from the colonoscope by folds, including 24.3% more adenomas at least 6 mm in diameter and 19.0% more adenomas at least 10 mm.

Relevant articles in Gastrointestinal Endoscopy: Adenoma detection and retroscopy; Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group

Product page: Third Eye® Retroscope®

Flashbacks: Third Eye Retroscope Wins FDA OK ; It's a Retrospectroscope... It's a Rectospectroscope...No It's Retroscope!

Device demo video and more after the fold:

Full press release obtained by Medgadget:

Two Studies Published in Gastrointestinal Endoscopy Confirm that the Third Eye® Retroscope® Finds More Pre-Cancerous Polyps during Colonoscopy
SUNNYVALE, Calif. (March 9, 2010) – Avantis Medical Systems, Inc., a technology leader in developing novel catheter-mounted digital imaging devices, today announced the publication of two large clinical studies demonstrating that the Third Eye® Retroscope® helps physicians find more pre-cancerous polyps in the colon. Both studies were published in the March 2010 issue of Gastrointestinal Endoscopy, the leading journal for gastroenterologists, colorectal surgeons and other physicians who perform colonoscopy. The Third Eye Retroscope is a catheter-based camera that is inserted through the instrument channel of a standard colonoscope to provide the physician with a retrograde (backward) view of the lining of the colon. This retrograde view can reveal lesions that are hidden behind folds where they can’t be seen with the colonoscope’s forward view alone. The first study was led by Dr. Jerome D. Waye, Clinical Professor of Medicine at Mount Sinai School of Medicine, New York, NY. Titled “A Retrograde-Viewing Device Improves Detection of Adenomas in the Colon: A Prospective Efficacy Evaluation,” the study involved 14 investigators and 249 patients at 8 medical centers in the U.S.1 The investigators found that the Third Eye improved detection and removal of polyps by 13.2% compared to the colonoscope alone. For adenomas, the polyps that are most likely to become cancers over time, the additional detection rate with the Third Eye was 11.0% for lesions of all sizes. For medium-size adenomas (at least 6 mm in diameter), the additional detection rate with the Third Eye was 25.0%, and for large adenomas (at least 10 mm), they found 33.3% more with the Third Eye. Thus, the Third Eye not only allowed for identification of more polyps, but its greatest yield was in the detection of larger adenomas, which are further along in the progression to cancer. “These data have a very real impact on patients, who benefit when the Third Eye helps us find adenomas and other polyps that otherwise might have been missed during colonoscopy,” said Dr. Waye. “Colorectal cancer is the second leading cause of cancer deaths in the United States, but it is preventable through the early detection of pre-cancerous lesions. The data show that the Third Eye enhances our ability to detect adenomas, and we believe that will improve long-term patient outcomes.” The second study was led by Dr. Daniel C. DeMarco, Director of Endoscopy at Baylor University Medical Center, Dallas, TX. Titled “Impact of Experience with a Retrograde-Viewing Device on Adenoma Detection Rates and Withdrawal Times during Colonoscopy: the Third Eye Retroscope Study Group,” the study involved 298 patients at 9 U.S. sites, and was conducted by 17 investigators who had not previously used the device.2 Overall, beginning with the very first time they used the device, the Third Eye allowed the investigators to find 16.0% more adenomas in addition to those they were able to find with the colonoscope alone. However, after each investigator had gained some experience with the device by performing 15 procedures, their average additional adenoma detection rate with the Third Eye compared to the colonoscope alone was 25.0%. Again considering their overall results from start to finish, the endoscopists found a higher proportion of larger pre-cancerous adenomas that were hidden from the colonoscope by folds, including 24.3% more adenomas at least 6 mm in diameter and 19.0% more adenomas at least 10 mm. “Previous studies have shown that 22 to 24% of adenomas of all sizes and 12% of adenomas over 10 mm in diameter are missed with the standard colonoscope,” said Dr. DeMarco, the Principal Investigator. “This study showed that after completing only 15 procedures with the new device, the investigators achieved a 25% mean additional adenoma detection rate, which resembles the well-documented miss rate for the colonoscope alone. This is exciting because cancer is prevented when we find and remove adenomas before they have a chance to progress to cancer.” “We are very pleased with the results of these two studies,” said Dr. Jack Higgins, Chief Medical Officer of Avantis Medical Systems. “Collectively, the Waye study and DeMarco study included results from 547 patients. Both of these studies demonstrated that adenoma detection rates can be significantly improved through use of the Third Eye, especially for the larger adenomas that are most clinically significant. It makes sense that lesions that are hidden behind folds where they can be found only with the Third Eye were likely missed during previous exams, so they’ve had time to grow larger and potentially more dangerous.” The Third Eye was shown to be extremely safe, and there were no adverse events resulting from use of the device in either of the studies. About the Studies The objective of the 249-patient, 8-center study led by Dr. Waye was to evaluate the added benefit for polyp detection during colonoscopy using a retrograde-viewing device. The study results included:

* 257 polyps (including 136 adenomas) were identified with the colonoscope alone. The Third Eye allowed detection of 34 additional polyps – including 15 additional pre-cancerous adenomas that were hidden from the view of the colonoscope because they were located behind folds.
* For lesions 6 mm or larger, the mean additional detection rates with the Third Eye Retroscope were 18.2% for all polyps and 25.0%for adenomas.
* For lesions 10 mm or larger, the additional detection rates with the Third Eye were 30.8% for all polyps and 33.3% for adenomas.
* In 28 individuals (11.2%), at least 1 additional polyp was found with the Third Eye.


The objective of the 298-patient, 9-center study led by Dr. DeMarco was to evaluate whether experience with the Third Eye Retroscope affects polyp detection rates and procedure times in physicians who were experienced colonoscopists but who had not previously used the Third Eye except during training with a plastic model of the colon. The study findings included:

* Overall, 182 polyps were seen with the colonoscope and 27 additional polyps were detected with the Third Eye Retroscope, a 14.8% increase.
* Overall, 100 adenomas were detected with the colonoscope and 16 more with the Third Eye Retroscope, a 16.0% increase.
* For procedures performed after each physician had completed 15 procedures, the mean additional detection rates with the Third Eye Retroscope were 17.0% for all polyps and 25.0% for adenomas.
* For lesions 6 mm or larger, the overall additional detection rates with the Third Eye Retroscope were 23.2% for all polyps and 24.3% for adenomas.
* For lesions 10 mm or larger, the overall additional detection rates with the Third Eye were 22.6% for all polyps and 19.0% for adenomas.
* In 27 patients (9.1%), at least 1 additional polyp was found with the Third Eye.


About Gastrointestinal Endoscopy
Gastrointestinal Endoscopy is the official journal of the American Society for Gastrointestinal Endoscopy. Gastrointestinal Endoscopy publishes original, peer-reviewed articles on endoscopic procedures used in the study, diagnosis and treatment of digestive diseases. Articles report on outcomes research, prospective studies and controlled trials of new endoscopic instruments and treatment methods. Gastrointestinal Endoscopy has become the international forum for the newest developments in the specialty, bringing readers challenging reports from leading authorities throughout the world.

About the Third Eye Retroscope and Avantis Medical Systems, Inc.
Avantis Medical Systems, Inc. markets the Third Eye Retroscope, an FDA-cleared, disposable, catheter-based camera indicated for use with a standard colonoscope to provide an additional view of the colon for diagnostic purposes. Deployed through the instrument channel of a standard colonoscope, the Third Eye provides the physician with a backward view to complement the colonoscope’s forward view of the lining of the colon. The device is commercially available to physicians who perform colonoscopies.

The Third Eye is the only technology cleared by the FDA that enhances polyp detection when used in conjunction with a colonoscope. Although colonoscopy is the gold standard for preventing colon cancer by finding and removing polyps and other lesions, clinical literature documents that up to 22-24% of adenomas of all sizes3,4 and 12% of adenomas over 10 mm in size5 can be missed. The Third Eye has been shown in clinical studies to help physicians find up to 25% more adenomas than a standard colonoscope alone.

Avantis Medical is focused on delivering cost-effective solutions for improved detection and prevention of cancers of the gastrointestinal tract. The company has an extensive portfolio of patents covering innovative devices based on the convergent technologies of micro-chips, enhanced video processing and catheter-based delivery systems. For more information, visit www.AvantisMedical.com or www.ThirdEyeRetroscope.com.



Source: Medgadget
Categories: All , Technical
14:17

The Third Eye Retroscope from Avantis Medical Systems (Sunnyvale, CA) is getting some good reviews in two studies just published in Gastrointestinal Endoscopy. The device works in conjunction with a standard colonoscope to look behind, kind of like a rear view mirror in a car. And as designed, this device is proving valuable in spotting polyps that would otherwise have gone unnoticed.

From an Avantis Medical press release:

The first study was led by Dr. Jerome D. Waye, Clinical Professor of Medicine at Mount Sinai School of Medicine, New York, NY. Titled “A Retrograde-Viewing Device Improves Detection of Adenomas in the Colon: A Prospective Efficacy Evaluation,” the study involved 14 investigators and 249 patients at 8 medical centers in the U.S.1 The investigators found that the Third Eye improved detection and removal of polyps by 13.2% compared to the colonoscope alone. For adenomas, the polyps that are most likely to become cancers over time, the additional detection rate with the Third Eye was 11.0% for lesions of all sizes. For medium-size adenomas (at least 6 mm in diameter), the additional detection rate with the Third Eye was 25.0%, and for large adenomas (at least 10 mm), they found 33.3% more with the Third Eye. Thus, the Third Eye not only allowed for identification of more polyps, but its greatest yield was in the detection of larger adenomas, which are further along in the progression to cancer.

The second study was led by Dr. Daniel C. DeMarco, Director of Endoscopy at Baylor University Medical Center, Dallas, TX. Titled “Impact of Experience with a Retrograde-Viewing Device on Adenoma Detection Rates and Withdrawal Times during Colonoscopy: the Third Eye Retroscope Study Group,” the study involved 298 patients at 9 U.S. sites, and was conducted by 17 investigators who had not previously used the device.2

Overall, beginning with the very first time they used the device, the Third Eye allowed the investigators to find 16.0% more adenomas in addition to those they were able to find with the colonoscope alone. However, after each investigator had gained some experience with the device by performing 15 procedures, their average additional adenoma detection rate with the Third Eye compared to the colonoscope alone was 25.0%. Again considering their overall results from start to finish, the endoscopists found a higher proportion of larger pre-cancerous adenomas that were hidden from the colonoscope by folds, including 24.3% more adenomas at least 6 mm in diameter and 19.0% more adenomas at least 10 mm.

Relevant articles in Gastrointestinal Endoscopy: Adenoma detection and retroscopy; Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group

Product page: Third Eye® Retroscope®

Flashbacks: Third Eye Retroscope Wins FDA OK ; It's a Retrospectroscope... It's a Rectospectroscope...No It's Retroscope!

Device demo video and more after the fold:

Full press release obtained by Medgadget:

Two Studies Published in Gastrointestinal Endoscopy Confirm that the Third Eye® Retroscope® Finds More Pre-Cancerous Polyps during Colonoscopy
SUNNYVALE, Calif. (March 9, 2010) – Avantis Medical Systems, Inc., a technology leader in developing novel catheter-mounted digital imaging devices, today announced the publication of two large clinical studies demonstrating that the Third Eye® Retroscope® helps physicians find more pre-cancerous polyps in the colon. Both studies were published in the March 2010 issue of Gastrointestinal Endoscopy, the leading journal for gastroenterologists, colorectal surgeons and other physicians who perform colonoscopy. The Third Eye Retroscope is a catheter-based camera that is inserted through the instrument channel of a standard colonoscope to provide the physician with a retrograde (backward) view of the lining of the colon. This retrograde view can reveal lesions that are hidden behind folds where they can’t be seen with the colonoscope’s forward view alone. The first study was led by Dr. Jerome D. Waye, Clinical Professor of Medicine at Mount Sinai School of Medicine, New York, NY. Titled “A Retrograde-Viewing Device Improves Detection of Adenomas in the Colon: A Prospective Efficacy Evaluation,” the study involved 14 investigators and 249 patients at 8 medical centers in the U.S.1 The investigators found that the Third Eye improved detection and removal of polyps by 13.2% compared to the colonoscope alone. For adenomas, the polyps that are most likely to become cancers over time, the additional detection rate with the Third Eye was 11.0% for lesions of all sizes. For medium-size adenomas (at least 6 mm in diameter), the additional detection rate with the Third Eye was 25.0%, and for large adenomas (at least 10 mm), they found 33.3% more with the Third Eye. Thus, the Third Eye not only allowed for identification of more polyps, but its greatest yield was in the detection of larger adenomas, which are further along in the progression to cancer. “These data have a very real impact on patients, who benefit when the Third Eye helps us find adenomas and other polyps that otherwise might have been missed during colonoscopy,” said Dr. Waye. “Colorectal cancer is the second leading cause of cancer deaths in the United States, but it is preventable through the early detection of pre-cancerous lesions. The data show that the Third Eye enhances our ability to detect adenomas, and we believe that will improve long-term patient outcomes.” The second study was led by Dr. Daniel C. DeMarco, Director of Endoscopy at Baylor University Medical Center, Dallas, TX. Titled “Impact of Experience with a Retrograde-Viewing Device on Adenoma Detection Rates and Withdrawal Times during Colonoscopy: the Third Eye Retroscope Study Group,” the study involved 298 patients at 9 U.S. sites, and was conducted by 17 investigators who had not previously used the device.2 Overall, beginning with the very first time they used the device, the Third Eye allowed the investigators to find 16.0% more adenomas in addition to those they were able to find with the colonoscope alone. However, after each investigator had gained some experience with the device by performing 15 procedures, their average additional adenoma detection rate with the Third Eye compared to the colonoscope alone was 25.0%. Again considering their overall results from start to finish, the endoscopists found a higher proportion of larger pre-cancerous adenomas that were hidden from the colonoscope by folds, including 24.3% more adenomas at least 6 mm in diameter and 19.0% more adenomas at least 10 mm. “Previous studies have shown that 22 to 24% of adenomas of all sizes and 12% of adenomas over 10 mm in diameter are missed with the standard colonoscope,” said Dr. DeMarco, the Principal Investigator. “This study showed that after completing only 15 procedures with the new device, the investigators achieved a 25% mean additional adenoma detection rate, which resembles the well-documented miss rate for the colonoscope alone. This is exciting because cancer is prevented when we find and remove adenomas before they have a chance to progress to cancer.” “We are very pleased with the results of these two studies,” said Dr. Jack Higgins, Chief Medical Officer of Avantis Medical Systems. “Collectively, the Waye study and DeMarco study included results from 547 patients. Both of these studies demonstrated that adenoma detection rates can be significantly improved through use of the Third Eye, especially for the larger adenomas that are most clinically significant. It makes sense that lesions that are hidden behind folds where they can be found only with the Third Eye were likely missed during previous exams, so they’ve had time to grow larger and potentially more dangerous.” The Third Eye was shown to be extremely safe, and there were no adverse events resulting from use of the device in either of the studies. About the Studies The objective of the 249-patient, 8-center study led by Dr. Waye was to evaluate the added benefit for polyp detection during colonoscopy using a retrograde-viewing device. The study results included:

* 257 polyps (including 136 adenomas) were identified with the colonoscope alone. The Third Eye allowed detection of 34 additional polyps – including 15 additional pre-cancerous adenomas that were hidden from the view of the colonoscope because they were located behind folds.
* For lesions 6 mm or larger, the mean additional detection rates with the Third Eye Retroscope were 18.2% for all polyps and 25.0%for adenomas.
* For lesions 10 mm or larger, the additional detection rates with the Third Eye were 30.8% for all polyps and 33.3% for adenomas.
* In 28 individuals (11.2%), at least 1 additional polyp was found with the Third Eye.


The objective of the 298-patient, 9-center study led by Dr. DeMarco was to evaluate whether experience with the Third Eye Retroscope affects polyp detection rates and procedure times in physicians who were experienced colonoscopists but who had not previously used the Third Eye except during training with a plastic model of the colon. The study findings included:

* Overall, 182 polyps were seen with the colonoscope and 27 additional polyps were detected with the Third Eye Retroscope, a 14.8% increase.
* Overall, 100 adenomas were detected with the colonoscope and 16 more with the Third Eye Retroscope, a 16.0% increase.
* For procedures performed after each physician had completed 15 procedures, the mean additional detection rates with the Third Eye Retroscope were 17.0% for all polyps and 25.0% for adenomas.
* For lesions 6 mm or larger, the overall additional detection rates with the Third Eye Retroscope were 23.2% for all polyps and 24.3% for adenomas.
* For lesions 10 mm or larger, the overall additional detection rates with the Third Eye were 22.6% for all polyps and 19.0% for adenomas.
* In 27 patients (9.1%), at least 1 additional polyp was found with the Third Eye.


About Gastrointestinal Endoscopy
Gastrointestinal Endoscopy is the official journal of the American Society for Gastrointestinal Endoscopy. Gastrointestinal Endoscopy publishes original, peer-reviewed articles on endoscopic procedures used in the study, diagnosis and treatment of digestive diseases. Articles report on outcomes research, prospective studies and controlled trials of new endoscopic instruments and treatment methods. Gastrointestinal Endoscopy has become the international forum for the newest developments in the specialty, bringing readers challenging reports from leading authorities throughout the world.

About the Third Eye Retroscope and Avantis Medical Systems, Inc.
Avantis Medical Systems, Inc. markets the Third Eye Retroscope, an FDA-cleared, disposable, catheter-based camera indicated for use with a standard colonoscope to provide an additional view of the colon for diagnostic purposes. Deployed through the instrument channel of a standard colonoscope, the Third Eye provides the physician with a backward view to complement the colonoscope’s forward view of the lining of the colon. The device is commercially available to physicians who perform colonoscopies.

The Third Eye is the only technology cleared by the FDA that enhances polyp detection when used in conjunction with a colonoscope. Although colonoscopy is the gold standard for preventing colon cancer by finding and removing polyps and other lesions, clinical literature documents that up to 22-24% of adenomas of all sizes3,4 and 12% of adenomas over 10 mm in size5 can be missed. The Third Eye has been shown in clinical studies to help physicians find up to 25% more adenomas than a standard colonoscope alone.

Avantis Medical is focused on delivering cost-effective solutions for improved detection and prevention of cancers of the gastrointestinal tract. The company has an extensive portfolio of patents covering innovative devices based on the convergent technologies of micro-chips, enhanced video processing and catheter-based delivery systems. For more information, visit www.AvantisMedical.com or www.ThirdEyeRetroscope.com.



Source: Medgadget
Categories: All , Technical
14:12
NEW YORK & SAN FRANCISCO--(BUSINESS WIRE)--Mar 3, 2010 - Pfizer  Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) today announced results from two Phase 3 trials of the investigational drug dimebon (latrepirdine*) in patients with Alzheimer's disease (AD). In the CONNECTION trial, dimebon did not meet its co-primary or secondary efficacy endpoints compared to placebo. Co-primary endpoints were measures of cognition and global function.

“The results from the CONNECTION study are unexpected, and we are disappointed for the Alzheimer's community,” said Dr. David Hung, president and chief executive officer of Medivation. “We are working with our colleagues at Pfizer to better understand the CONNECTION data and we plan to present these data at an upcoming medical meeting.”

Dimebon was well tolerated in both the CONNECTION study and in a separate Phase 3 safety and tolerability study, which confirmed dimebon's tolerability when dosed alone or in combination with approved Alzheimer's disease medicines.

“We are evaluating the CONNECTION data with Medivation. After that review, Pfizer will be in a position to determine appropriate next steps regarding the dimebon program,” said Dr. Briggs W. Morrison, senior vice president, clinical development, Primary Care Business Unit at Pfizer. “We recognize the significant medical need, and we are committed to advancing treatment options for Alzheimer's disease."

About the CONNECTION Study

CONNECTION is a Phase 3, multi-national, double-blind, placebo-controlled safety and efficacy trial involving 598 patients with mild-to-moderate AD at 63 sites in North America, Europe, and South America. Patients had a mean age of 74.4 years and a mean score of 17.7 on the Mini-Mental State Examination (MMSE) upon entry into the study. More than 40 percent of the patients enrolled were in the United States. In the study, patients were randomized to one of three treatment groups, receiving dimebon 20 mg three times a day (TID), dimebon 5 mg TID, or placebo TID for six months. The 5 mg arm was included in the study to help define the effective dose range for dimebon treatment.

No statistically significant improvements for the 20 mg TID group relative to placebo were achieved on the co-primary endpoints. One primary endpoint evaluated the effect of dimebon on cognition, as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), and showed that dimebon-treated patients achieved a 0.1 point difference from patients receiving placebo (p=0.86). Neither group was significantly changed from baseline. The other primary endpoint evaluated the effect of dimebon on independently-rated global function over the course of the six-month trial, as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus; p=0.81). According to the CIBIC-plus scale, 64.9 percent of the patients treated with dimebon 20 mg TID showed improvement or no change at Week 26 compared to 65.4 percent of placebo-treated patients. Results for the dimebon 5 mg dose were similar to the dimebon 20 mg and placebo, although they were numerically lower.

The 20 mg TID dimebon-treated patients also showed no statistically significant differences compared to placebo on the secondary efficacy endpoints. After six months of treatment, patients treated with dimebon showed a 0.4 point difference from patients taking placebo on activities of daily living (p=0.61), as measured by the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL). Neither group was significantly changed from baseline. The dimebon-treated group showed a 1.6 point improvement on behavior compared to placebo (p=0.17), as measured by the Neuropsychiatric Inventory (NPI). Compared to baseline, each group was improved, but this change was only significant for the dimebon group. On the Mini Mental State Examination (MMSE), another measure of cognition, both groups improved significantly over baseline (dimebon 0.7; placebo 1.2). The difference favoring placebo was not significant (p=0.10). Results for the dimebon 5 mg dose were similar to dimebon 20 mg and placebo, although they were numerically lower. Dimebon, 20 mg orally three-times daily, was well tolerated in the study. The number of patients with at least one adverse event was similar in the dimebon 20 mg and placebo groups (72.0% vs. 74.2%, respectively). The most frequently reported adverse events (>5%) in patients in the 20 mg dimebon group occurring more commonly than in the placebo group included somnolence (11.0% vs. 10.1%), dry mouth (8.5% vs. 6.6%), headache (9.5% vs. 5.6%), dizziness (7.5% vs. 5.1%), constipation (5.5% vs. 3.5%), cough (7.5% vs. 3.5%) and depression (6.0% vs. 3.5%). Similar rates of adverse events were observed for the 5 mg TID group. No clinically significant findings were noted in assessment of vital signs, clinical laboratories or on electrocardiography (ECG).

About the Phase 3 Safety and Tolerability Study

In a separate multi-center, placebo-controlled Phase 3 safety and tolerability study, dimebon was well tolerated when given alone or in combination with a variety of other AD medicines, including cholinesterase inhibitors, memantine, or both. Previous studies have confirmed the tolerability of dimebon alone. The Phase 3 safety and tolerability study enrolled 742 patients with mild-to-moderate Alzheimer's disease in the United States and Canada. In this study, patients were randomized to either dimebon 20 mg three-times daily or placebo and were treated for a period of either three or six months. Approximately 85 percent of patients were taking one or more currently approved Alzheimer's disease medicines while participating in this study.

Dimebon was well tolerated in the study. The most frequently reported adverse events (>5%) in the dimebon group occurring more commonly than in the placebo group were somnolence (5.1% vs. 1.9%) and fatigue (5.1% vs. 2.4%). No clinically significant findings were noted in assessment of vital signs, clinical laboratories or on electrocardiography (ECG).

About Dimebon

Dimebon (latrepirdine*) is an investigational oral medication being tested as a potential treatment for Alzheimer's disease and Huntington disease. Dimebon is being studied in four other ongoing randomized, double-blind, placebo-controlled Phase 3 studies, which currently are enrolling. The CONCERT trial is a 12-month study testing dimebon in patients with mild-to-moderate Alzheimer's disease who are taking donepezil, a commonly prescribed Alzheimer's disease medication. The CONTACT and CONSTELLATION trials are six-month trials testing dimebon in patients with moderate-to-severe Alzheimer's disease taking currently approved AD medications. In CONTACT, subjects must also be taking donepezil, while in CONSTELLATION they must also be taking memantine, another commonly prescribed Alzheimer's disease medication. Dimebon is also being tested in the HORIZON trial, a six-month study evaluating dimebon in patients with Huntington disease.

For information on dimebon clinical trials, please visit www.dimebontrials.com or www.clinicaltrials.gov.

About Alzheimer's Disease

Alzheimer's disease is a progressive degenerative brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as delusions, hallucinations, anxiety and agitation.

About the Pfizer/Medivation Dimebon Collaboration

Medivation and Pfizer have a global collaboration to develop and commercialize dimebon for the treatment of Alzheimer's disease and Huntington disease. Under the terms of the agreement, the companies work together on the dimebon development program.

For more information about Pfizer, visit www.Pfizer.com.

For more information about Medivation, visit www.Medivation.com.

*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.

Medivation Investor Conference Call Details:

Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the live call please dial 877-303-2523 for domestic callers and 1-253-237-1755 for international callers. In addition, the live conference call is being webcast and can be accessed on the "Events and Presentations" page of the "Investor Relations" section of the Company's website at www.medivation.com. A replay also will be available for 30 days following the live call.

Forward-Looking Statements

PFIZER DISCLOSURE NOTICE: The information contained in this release is as of March 3, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information that involves substantial risks and uncertainties about certain potential indications for dimebon, including their potential benefits; the continued clinical development of dimebon; and the continuing collaborative activities under our collaboration with Medivation. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including risks related to the progress, timing and results of the clinical trials for dimebon; decisions by regulatory authorities regarding whether and when to approve any new drug applications that may be filed for such indications, including the risk that such indications may never be approved for commercial sale in any jurisdiction, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such indications, and competitive developments.

A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

MEDIVATION DISCOSURE NOTICE: This press release contains forward-looking statements, including statements regarding the continued clinical development of dimebon, the continued effectiveness of, and continuing collaborative activities under, our collaboration with Pfizer, potential clinical indications for dimebon, including its potential benefits, and potential regulatory approval and commercialization of dimebon, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation's actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation's clinical trials, including the risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of our dimebon development activities, difficulties or delays in obtaining regulatory approval, including the risk that dimebon may never be approved for commercial sale in any jurisdiction, enrollment of patients in Medivation's clinical trials, partnering of Medivation's product candidates, including Medivation's dependence on the efforts of and funding by Pfizer for the development of dimebon under its collaboration with Pfizer, which collaboration may be unilaterally terminated by Pfizer at its election at any time, the achievement of development, regulatory and commercial milestones under Medivation's collaboration agreement with Pfizer, manufacturing of Medivation's product candidates, including Medivation's dependence on Pfizer for the manufacture of all clinical requirements of dimebon, competition with Medivation's product candidates should they receive marketing approval, the adequacy of Medivation's financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation's filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended September 30, 2009, filed with the SEC on November 4, 2009. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

Contact: Pfizer Inc.
Media:
MacKay Jimeson, 212-733-2324
or
Investors:
Suzanne Harnett, 212-733-8009
or
Medivation, Inc.
Patrick Machado, 415-829-4101
Chief Business Officer


14:01


St. Jude Medical is touting results of a recently published study that analyzed the clinical benefits of frequent and regular left atrial pressure (LAP) monitoring in patients with heart failure. In the study, patients wore a special device, called HeartPOD, that monitored their LAP and routed the data wirelessly to their cardiologist. The physician, in turn, was able to adjust the prescription drug dosage taken by the patient on a daily basis. The results show that this leads to better overall outcomes for patients and a greater understanding of the condition for the physicians involved.

The above picture was given to us by St. Jude Medical. And we think it has a clue as to the future of this technology. Imagine this kind of monitoring shows more and more positive outcomes in the future clinical studies, and it wins all needed regulatory approvals. One day we might be seeing these pressure monitoring sensors embedded into the electrodes of AICDs and pacemakers. Wouldn't that be neat?

Results from this study demonstrated that regular monitoring of LAP in combination with a dynamically adjusted prescription plan can be used to drive appropriate adjustment of HF treatments, and as a result, improved LAP control and reduction of HF events that may result in hospitalization or death.

Following implantation of an LAP sensor, all subjects in the study were free of major adverse cardiac and neurological events at six weeks, meeting the trial's primary endpoint. Over a median follow-up of 25 months, LAP control was achieved for at least six consecutive months in 76 percent of patients, with a 67 percent reduction in the frequency of elevated LAP readings (over 25 mmHg). Throughout this same period, there was a significant 84 percent average decrease in HF events including HF hospitalization and all-cause mortality once LAP-guided therapy was initiated. Over the course of treatment, patients also had significant improvements in HF symptoms and quality of life.

The report outlined results of the first 40 patients enrolled in the trial; 20 patients enrolled in three Australian or New Zealand sites and 20 patients enrolled in four U.S. sites.

The early results of the HOMEOSTASIS trial led to the establishment of the LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) Study, a larger pivotal, randomized, controlled, prospective, multi-center clinical investigation. The LAPTOP-HF study will be conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and is expected to begin in the first half of 2010.

Abstract in Circulation: Physician-Directed Patient Self-Management of Left Atrial Pressure in Advanced Chronic Heart Failure

Press release: St. Jude Medical Announces Publication of Feasibility Results for Trial of Novel Heart Failure Management System ...

Medgadget 2005 flashback: HeartPOD...



Source: Medgadget
Categories: All , Technical
14:01


St. Jude Medical is touting results of a recently published study that analyzed the clinical benefits of frequent and regular left atrial pressure (LAP) monitoring in patients with heart failure. In the study, patients wore a special device, called HeartPOD, that monitored their LAP and routed the data wirelessly to their cardiologist. The physician, in turn, was able to adjust the prescription drug dosage taken by the patient on a daily basis. The results show that this leads to better overall outcomes for patients and a greater understanding of the condition for the physicians involved.

The above picture was given to us by St. Jude Medical. And we think it has a clue as to the future of this technology. Imagine this kind of monitoring shows more and more positive outcomes in the future clinical studies, and it wins all needed regulatory approvals. One day we might be seeing these pressure monitoring sensors embedded into the electrodes of AICDs and pacemakers. Wouldn't that be neat?

Results from this study demonstrated that regular monitoring of LAP in combination with a dynamically adjusted prescription plan can be used to drive appropriate adjustment of HF treatments, and as a result, improved LAP control and reduction of HF events that may result in hospitalization or death.

Following implantation of an LAP sensor, all subjects in the study were free of major adverse cardiac and neurological events at six weeks, meeting the trial's primary endpoint. Over a median follow-up of 25 months, LAP control was achieved for at least six consecutive months in 76 percent of patients, with a 67 percent reduction in the frequency of elevated LAP readings (over 25 mmHg). Throughout this same period, there was a significant 84 percent average decrease in HF events including HF hospitalization and all-cause mortality once LAP-guided therapy was initiated. Over the course of treatment, patients also had significant improvements in HF symptoms and quality of life.

The report outlined results of the first 40 patients enrolled in the trial; 20 patients enrolled in three Australian or New Zealand sites and 20 patients enrolled in four U.S. sites.

The early results of the HOMEOSTASIS trial led to the establishment of the LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) Study, a larger pivotal, randomized, controlled, prospective, multi-center clinical investigation. The LAPTOP-HF study will be conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and is expected to begin in the first half of 2010.

Abstract in Circulation: Physician-Directed Patient Self-Management of Left Atrial Pressure in Advanced Chronic Heart Failure

Press release: St. Jude Medical Announces Publication of Feasibility Results for Trial of Novel Heart Failure Management System ...

Medgadget 2005 flashback: HeartPOD...



Source: Medgadget
Categories: All , Technical
13:58

Next week at the Intercompany Long Term Care Insurance Conference (ILTCI) in New Orleans, Robosoft a company out of Bidart, France, will unveil a new robot that can assist the elderly and dependent in their own home. Although the video below spotlights some impressive capabilities, the robot has no hands to bring you a cup of water and is essentially a Dell laptop on wheels.

From Robosoft's press release:

Kompaï is intended to help dependent persons in their daily lives. It is a mobile and communicative product. Somewhat like a dog, it has its "basket", which is the recharging dock that it heads back to when its batteries are low. Equipped with speech, it is able to understand simple orders and give a certain level of response. It knows its position within the house, how to get from one point to another on demand or on its own initiative, and it remains permanently connected to the internet and all its associated services.

Its primary means of communication with people is speech, with an additional touch screen that features simple icons. Future generations of Kompaï will be equipped with visual abilities, and also the possibility to understand and express emotions. And later, the addition of arms will allow it to handle objects, leading to meal preparation and tidying; more practical functions, yet still fundamental in everyday life.

Press release: Robosoft introduces Kompaï...



Source: Medgadget
Categories: All , Technical
13:58

Next week at the Intercompany Long Term Care Insurance Conference (ILTCI) in New Orleans, Robosoft a company out of Bidart, France, will unveil a new robot that can assist the elderly and dependent in their own home. Although the video below spotlights some impressive capabilities, the robot has no hands to bring you a cup of water and is essentially a Dell laptop on wheels.

From Robosoft's press release:

Kompaï is intended to help dependent persons in their daily lives. It is a mobile and communicative product. Somewhat like a dog, it has its "basket", which is the recharging dock that it heads back to when its batteries are low. Equipped with speech, it is able to understand simple orders and give a certain level of response. It knows its position within the house, how to get from one point to another on demand or on its own initiative, and it remains permanently connected to the internet and all its associated services.

Its primary means of communication with people is speech, with an additional touch screen that features simple icons. Future generations of Kompaï will be equipped with visual abilities, and also the possibility to understand and express emotions. And later, the addition of arms will allow it to handle objects, leading to meal preparation and tidying; more practical functions, yet still fundamental in everyday life.

Press release: Robosoft introduces Kompaï...



Source: Medgadget
Categories: All , Technical
13:15

Watch the White House Health Care Summit here (live beginning at 10:00 am EST today, or later), and check out the President's health reform proposal, too.  (Video is archived on this site as well.)

Update 3/2/10:

Obama Letter to Congressional Leaders After Health Care Summit

David Harlow
The Harlow Group LLC
Health Care Law and Consulting
Source: HealthBlawg
12:23

Nuance Communications (Burlington, MA), makers of the popular Dragon Naturally Speaking voice recognition software, have unveiled new smart phone apps specifically developed for clinical professionals. The Dragon Medical Mobile package provides transcription, medical voice search, and voice recording capabilities. There's also a software development kit (SDK) available to allow other firms to integrate Dragon Medical voice recognition ability into their own applications.

By utilizing Nuance's advanced, cloud-based Dragon Medical speech recognition technology, clinicians can dictate and capture information via a smartphone in real-time without having to return to the desktop or rely on the keyboard or touch screen. With Dragon Medical Mobile Dictation, all of the speech recognition is performed in the cloud using advanced real-time streaming capabilities.

Utilizing the same cloud-based speech recognition technology as the Dragon Medical Mobile Dictation app, the Search app will allow clinicians to simply speak a request to conduct fast and easy searches on various medical websites. A unique display carousel will show search results simultaneously from popular websites, including MedScape, MedLine, Epocrates and Google.

Once recorded, the clinicians' voice file is forwarded through Nuance's background speech recognition technology and onto transcription where a high quality draft document is created and then is sent back to the clinician for review and sign-off. The Dragon Medical Recorder app is designed for healthcare organizations that leverage either of Nuance's enterprise-wide speech-enabled dictation and transcription solutions, eScription or the Dictaphone Enterprise Speech System.

Press release: Nuance Extends Power and Experience of Mobile, Voice-Enabled Documentation and Search to the Healthcare Industry; Unveils Dragon Medical Mobile Apps for Smartphones ...

Product page: Dragon Medical Mobile Technologies for Smartphones ...



Source: Medgadget
Categories: All , Technical
12:23

Nuance Communications (Burlington, MA), makers of the popular Dragon Naturally Speaking voice recognition software, have unveiled new smart phone apps specifically developed for clinical professionals. The Dragon Medical Mobile package provides transcription, medical voice search, and voice recording capabilities. There's also a software development kit (SDK) available to allow other firms to integrate Dragon Medical voice recognition ability into their own applications.

By utilizing Nuance's advanced, cloud-based Dragon Medical speech recognition technology, clinicians can dictate and capture information via a smartphone in real-time without having to return to the desktop or rely on the keyboard or touch screen. With Dragon Medical Mobile Dictation, all of the speech recognition is performed in the cloud using advanced real-time streaming capabilities.

Utilizing the same cloud-based speech recognition technology as the Dragon Medical Mobile Dictation app, the Search app will allow clinicians to simply speak a request to conduct fast and easy searches on various medical websites. A unique display carousel will show search results simultaneously from popular websites, including MedScape, MedLine, Epocrates and Google.

Once recorded, the clinicians' voice file is forwarded through Nuance's background speech recognition technology and onto transcription where a high quality draft document is created and then is sent back to the clinician for review and sign-off. The Dragon Medical Recorder app is designed for healthcare organizations that leverage either of Nuance's enterprise-wide speech-enabled dictation and transcription solutions, eScription or the Dictaphone Enterprise Speech System.

Press release: Nuance Extends Power and Experience of Mobile, Voice-Enabled Documentation and Search to the Healthcare Industry; Unveils Dragon Medical Mobile Apps for Smartphones ...

Product page: Dragon Medical Mobile Technologies for Smartphones ...



Source: Medgadget
Categories: All , Technical
12:08


Rcadia Medical Imaging out of Haifa, Israel won European approval for the COR Analyzer software for identifying coronary artery stenosis from coronary CT angiography (cCTA) data. The app runs on standard PCs and will automatically process CT angiogram studies sent to it over the hospital network. The application then replies whether it identified a stenotic legion, pointing out to radiologists or cardiologists the area of concern.

Here's the application workflow and features of the COR Analyzer:

  • Isolate the heart region within a study

  • Find major anatomical structures

  • Locate the coronary artery tree and track the arteries

  • Label coronary artery segments

  • Segment the blood vessel internals and draw an accurate center line

  • Detect severe stenotic lesions
  • Findings can be easily verified and validated using simple visualization tools including standard 2-D projections, schematic 3-D and curved MPR views. The system automatically generates a report which includes a summary of findings and curved MPR snapshots. It can be easily edited by the physician to produce the final report.

    The automatically generated curved MPR images with marked detected lesions can be exported to any PACS/Workstation either manually or automatically upon completion of processing. These images will appear as secondary capture series for the corresponding study.

    Main features

  • Detects of significant coronary lesions

  • Displays 3D coronary tree & curved MPRs

  • Generates patient findings' reports

  • Exports to PACS and workstation

  • Runs on any 64-slice or higher CTA scanner

  • Product page: COR Analyzer System ...

    Press release: Rcadia Medical Imaging's COR Analyzer(R) System Receives CE Mark ...

    (hat tip: MassDevice)



    Source: Medgadget
    Categories: All , Technical
    12:08


    Rcadia Medical Imaging out of Haifa, Israel won European approval for the COR Analyzer software for identifying coronary artery stenosis from coronary CT angiography (cCTA) data. The app runs on standard PCs and will automatically process CT angiogram studies sent to it over the hospital network. The application then replies whether it identified a stenotic legion, pointing out to radiologists or cardiologists the area of concern.

    Here's the application workflow and features of the COR Analyzer:

  • Isolate the heart region within a study

  • Find major anatomical structures

  • Locate the coronary artery tree and track the arteries

  • Label coronary artery segments

  • Segment the blood vessel internals and draw an accurate center line

  • Detect severe stenotic lesions
  • Findings can be easily verified and validated using simple visualization tools including standard 2-D projections, schematic 3-D and curved MPR views. The system automatically generates a report which includes a summary of findings and curved MPR snapshots. It can be easily edited by the physician to produce the final report.

    The automatically generated curved MPR images with marked detected lesions can be exported to any PACS/Workstation either manually or automatically upon completion of processing. These images will appear as secondary capture series for the corresponding study.

    Main features

  • Detects of significant coronary lesions

  • Displays 3D coronary tree & curved MPRs

  • Generates patient findings' reports

  • Exports to PACS and workstation

  • Runs on any 64-slice or higher CTA scanner

  • Product page: COR Analyzer System ...

    Press release: Rcadia Medical Imaging's COR Analyzer(R) System Receives CE Mark ...

    (hat tip: MassDevice)



    Source: Medgadget
    Categories: All , Technical
    10:32

    What struck me at last week’s annual meeting of HIMSS (Health Information and Management Systems Society) was the conspicuous absence of conversation about the effect of the ARRA legislation on physician productivity—there was hardly a mention of the subject throughout the conference. Jeffrey Belden, M.D., of the HIMSS Usability Taskforce, did point out that documenting patient exams in an EMR takes 10 times as long as documenting by dictation, but offered no solution to that problem. Admittedly, the audience contained few, if any, physicians. However, once again, it struck me that physician productivity was the elephant in the room—the topic that no one was discussing, even though physicians are the very people upon whom the success of the program is so dependent.

    I arrived home to the release of the results of a new MGMA study (conducted last month), which concluded that practices expect that the operational changes required to meet the proposed meaningful use criteria will cause a significant decrease in productivity. Nearly 68% of the respondents anticipate such a decrease, with 31% projecting that the decrease would exceed 10%—and this was likely based on only the impact of Stage 1 meaningful use criteria.

    This productivity loss is what I described in last week’s EMR Straight Talk post, where ARRA meaningful use requirements compound the reduction in productivity that is already associated with the “point-and-click” EMRs themselves. Before ARRA, physicians estimated that traditional EMRs reduced their productivity by between 20% and 40%, as documented in testimonials posted on the Government’s FACA blog and included in the Voice of the Physician Petition. Others are speaking out about this issue as well; Paul Roemer reported that his cardiologist puts the productivity loss at 30%, due to the amount of time that he “wastes” performing clerical—i.e., data entry—tasks. (Read his comments in “Healthcare IT, How Good is Your Strategy: A Scathing Rebuke of EHR.”) Added together, this means that physicians face a 40% reduction in productivity at the outset. Imagine what will happen to productivity when the more stringent Stage 2 and 3 meaningful use criteria are implemented!

    The conclusion is clear. Physicians should not be considering EHR adoption for the incentive money; they should be looking at what will help them address their business and patient-care needs. The HIMSS keynote address by chairman Barry Chaiken, M.D., charged the EMR industry with “creating healthcare IT solutions that are so compelling, so irresistible, that people just want to use them.” Systems like that already exist—they just don’t interest the government, which appears to be more interested in data collection than EHR adoption.

    Related posts:

    1. Government EHR Program: Potentially Harmful Unintended Consequences
    2. I am really intrigued by the latest creation from the...
    3. Government EHR Program: Unintended Consequences (continued)
    4. Last week’s EMR Straight Talk, “Government EHR Program: Potentially Harmful...
    5. Government EHR: Teetering on the Backs of Physicians
    6. Last week, the HIT Policy Committee responded to CMS’ proposed...

    10:32

    What struck me at last week’s annual meeting of HIMSS (Health Information and Management Systems Society) was the conspicuous absence of conversation about the effect of the ARRA legislation on physician productivity—there was hardly a mention of the subject throughout the conference. Jeffrey Belden, M.D., of the HIMSS Usability Taskforce, did point out that documenting patient exams in an EMR takes 10 times as long as documenting by dictation, but offered no solution to that problem. Admittedly, the audience contained few, if any, physicians. However, once again, it struck me that physician productivity was the elephant in the room—the topic that no one was discussing, even though physicians are the very people upon whom the success of the program is so dependent.

    I arrived home to the release of the results of a new MGMA study (conducted last month), which concluded that practices expect that the operational changes required to meet the proposed meaningful use criteria will cause a significant decrease in productivity. Nearly 68% of the respondents anticipate such a decrease, with 31% projecting that the decrease would exceed 10%—and this was likely based on only the impact of Stage 1 meaningful use criteria.

    This productivity loss is what I described in last week’s EMR Straight Talk post, where ARRA meaningful use requirements compound the reduction in productivity that is already associated with the “point-and-click” EMRs themselves. Before ARRA, physicians estimated that traditional EMRs reduced their productivity by between 20% and 40%, as documented in testimonials posted on the Government’s FACA blog and included in the Voice of the Physician Petition. Others are speaking out about this issue as well; Paul Roemer reported that his cardiologist puts the productivity loss at 30%, due to the amount of time that he “wastes” performing clerical—i.e., data entry—tasks. (Read his comments in “Healthcare IT, How Good is Your Strategy: A Scathing Rebuke of EHR.”) Added together, this means that physicians face a 40% reduction in productivity at the outset. Imagine what will happen to productivity when the more stringent Stage 2 and 3 meaningful use criteria are implemented!

    The conclusion is clear. Physicians should not be considering EHR adoption for the incentive money; they should be looking at what will help them address their business and patient-care needs. The HIMSS keynote address by chairman Barry Chaiken, M.D., charged the EMR industry with “creating healthcare IT solutions that are so compelling, so irresistible, that people just want to use them.” Systems like that already exist—they just don’t interest the government, which appears to be more interested in data collection than EHR adoption.

    Related posts:

    1. Government EHR Program: Potentially Harmful Unintended Consequences
    2. I am really intrigued by the latest creation from the...
    3. Government EHR Program: Unintended Consequences (continued)
    4. Last week’s EMR Straight Talk, “Government EHR Program: Potentially Harmful...
    5. Government EHR: Teetering on the Backs of Physicians
    6. Last week, the HIT Policy Committee responded to CMS’ proposed...

    10:27


    On Thursday at HIMSS I attended a session called “Implementing and Measuring EMR ROI in the Specialty Practice” by Peter M. Deane, MD. This was the second such session that I attended. I was and am really interested in how practices are measuring the ROI in their clinic.

    I found this second session really interesting since Dr. Deane talked about the benefits he received from his EMR and yet, he still wasn’t doing his clinical notes electronically. Yes, it felt a little bit wrong to say that he uses an EMR when he isn’t writing his clinical notes electronically yet. However, what I found really interesting was that he was starting to see a whole laundry lists of benefits from his EMR even though he was only partially implemented.

    Honestly, I think that understanding the real benefits of an EMR in your practice is one of the keys to selecting and implementing an EMR. In fact, that’s why I have a whole section talking about the guaranteed, possible and dubious benefits of an EMR implementation in my just released EMR selection book.

    Back to the session, Dr. Deane had an interesting point about paper charts. In his slide it said, “Documentation is easy–to do poorly.” This is an interesting point, because I’ve found that EMR doesn’t necessarily take a doctor who is poor at documenting and make them better. However, what an EMR does do is hold people more accountable for what their documenting.

    Another key point that was offered in this session was in regards to the EMR selection process, “Decide: None is perfect, nor will the vendors ever by ‘ready’ for some.” I couldn’t agree more. Setting reasonable expectations is key to any successful EMR implementation. Go in with unreasonable expectations and you’re doomed for failure. That doesn’t mean you can’t be ambitious, but you can be reasonable at the same time.

    I also loved how Dr. Deane talked about the different types of leadership models in practices. He called them: “Command and control model (large institutional or central tyranny-style practices)” or “Consensus model (fraternity-style practice).” Understanding this dynamic is really important as you work to gain buy in for your EMR implementation.

    Another interesting insight he made was that people Fear Change. Ok, that’s not new. However, he clarified that “change means extra work” and “they also fear being left behind.” This is interesting advice during an EMR implementation. I guess the point being that pace of an EMR implementation matters.

    Dr. Deane also talked about the value of your EMR vendor customizing the EMR for you. I’ve seen the value of this first hand. It really does empower staff for your EMR vendor to do something for your office. Plus, it’s a real benefit to be able to point to those changes as your EMR progresses. Remember that EMR is a journey and not a one time event.

    Here’s a list of other EMR benefits he highlighted:
    -3 clerical positions ($70k per year)
    -Supplies and less printing ($3,500 per year)
    -Enhanced Reimbursement
    -Faster A/R turnover time
    -PQRI Incentives

    Not a bad session. Too bad it was on Thursday just before the closing keynote, so many at HIMSS had already gone home. Lucky for you, I stayed and could summarize it for you here;-)

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    9:44

    Researchers at the City of Paris Industrial Physics and Chemistry Higher Educational Institution (ESPCI) have shown that opaque substances can actually be viewed through, and can be made to perform like optical lenses, using laser light and a bit of mathematics. The technology may allow viewing of cells and other biological components through tissue that would otherwise shield them.

    In order to demonstrate their approach to characterize opaque substances, the researchers first passed light through a layer of zinc oxide, which is a common component of white paints. By studying the way the light beam changed as it encountered the material, they were able to produce a numerical model called a transmission matrix, which included over 65,000 numbers describing the way that the zinc oxide layer affected light. They could then use the matrix to tailor a beam of light specifically to pass through the layer and focus on the other side. Alternatively, they could measure light emerging from the opaque material, and use the matrix to assemble of an image of an object behind it.

    In effect, the experiment shows that an opaque material could serve as a high quality optical element comparable to a conventional lens, once a sufficiently detailed transmission matrix is constructed.

    Abstract in Physical Review Letters: Measuring the Transmission Matrix in Optics: An Approach to the Study and Control of Light Propagation in Disordered Media

    Viewpoint in APS Physics: The information age in optics: Measuring the transmission matrix

    More: Physicsists find a way to see through paint, paper, and other opaque materials ...



    Source: Medgadget
    Categories: All , Technical

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