FDA recognizes device interoperability standards, potentially smoothing 510(k) reviews

By: Neil Versel | Aug 13, 2013        

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FDA Senior Policy Advisor Bakul Patel

A decision by the Food and Drug Administration to recognize a set of voluntary, industry-developed interoperability standards should make it easier for technology developers to gain 510(k) clearance for new medical devices – including smartphone accessories – that follow such standards.

In its annual update to its list of accepted consensus standards for premarket reviews of medical devices, issued last week, the FDA included several items related to data exchange. Among the standards now accepted are ISO and IEEE specifications related to point-of-care and personal medical device communication for such categories as weight scales, thermometers, pulse oximeters, glucose meters, simple electrocardiographs and other devices that are increasingly being linked to smartphones and home monitoring stations.

The FDA also added standards for risk management of medical devices connected to wireless networks.

“This is the first time to my knowledge the FDA has recognized standards for interoperability,” Mary Logan, president of the Association for the Advancement of Medical Instrumentation (AAMI), told MobiHealthNews.

The AAMI and the FDA last year jointly convened a summit on medical device interoperability. A few months later, the agency and the trade group issued a report in which they said healthcare organizations needed to start paying closer attention to all the data being generated by connected medical devices. Keep reading>>


MyFitnessPal raises $18M from Kleiner Perkins, Accel Partners

By: Aditi Pai | Aug 12, 2013        

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myfitnesspalWellness tracking platform MyFitnessPal raised $18 million in the first round of funding led by Kleiner Perkins Caufield & Byers. Accel Partners also participated. Kleiner Perkins’ John Doerr and Accel Partners’ Andrew Braccia also joined MyFitnessPal’s board.

MyFitnessPal will use the funding to grow its team and expand to more countries. Already, the fitness system is available in some European and South American countries. Users can download the app in French, German, Spanish, and Brazilian Portuguese.

MyFitnessPal offers users a way to track fitness and diet trends. The system is available as an app on iOS and Android devices and offers support and coaching from experts as well as other users. MyFitnessPal has partnered with companies such as Fitbit, Withings, iHealth and Jawbone in order to sync wearable devices and apps to its program. Other app partnerships include Endomondo Sports Tracker, EveryMove, RunKeeper, Runtastic, Rhythm Pulse Monitor, Striiv Smart Play Pedometer and Digifit.

According to the company, MyFitnessPal has seen an increase of more than 1.5 million new users per month, and since its launch in September 2005, has amassed more than 40 million users.

Keep reading>>

Medtronic increases focus on home health with $200M Cardiocom buy

By: Jonah Comstock | Aug 12, 2013        

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Cardiocom's Diabetes Management System.

Cardiocom’s Diabetes Management System.

Minneapolis-based implantable medical device maker Medtronic has acquired Chanhassen, Minnesota-based Cardiocom, a remote patient monitoring and disease management company, for $200 million in cash. As the Wall Street Journal reported, this acquisition represents a diversification for Medtronic, from it’s core offering of implantable medical devices to home health monitors working to help providers reduce hospital readmissions.

“With broad healthcare reform initiatives focused on growing economic challenges, healthcare systems in every region of the world are striving to continuously improve outcomes, increase access, save cost, and improve the efficiency of healthcare delivery. The acquisition of Cardiocom is one step we are taking toward providing a combination of products and solutions that can help address those challenges,” Omar Ishrak, chairman and CEO of Medtronic, said in a statement.

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Wake Forest Medical Center, Novarus Healthcare to co-develop hospital apps

By: Aditi Pai | Aug 12, 2013        

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An example of an app that Novarus Healthcare previously developed.

Wake Forest Innovations, the commercialization arm of Wake Forest Baptist Medical Center, and Charlotte, North Carolina-based Novarus Healthcare signed a collaboration agreement to develop mobile apps. The partnership also includes a deal to collaborate on and commercialize the apps created.

As it is still early in the partnership, no apps have been finalized for production, but Wake Forest Innovations Executive Director of Commercialization Michael Batalia shared a few ideas with MobiHealthNews.

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Roundup: Startups, futurists, and the fate of Weight Watchers

By: Jonah Comstock | Aug 10, 2013        

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Weight Watchers online portal and app.

This week in mobile health, we saw FDA clearances for Alere and Verizon, trials from Scripps and Qualcomm, and some interesting new products in the consumer health sphere from Beddit, Emotiv, and BioBeats. Some other articles from around the web have also highlighted mobile health trends. Here’s some interesting pieces that caught our eyes this week.

The ObamaCare Start-Up Boom — TIME Magazine 

It’s nice to see a major magazine like TIME picking up on some of the trends in mobile health. In this piece, Christopher Matthews highlights a representative, if somewhat arbitrary, selection of health startups: IntelligentM, Care at Hand, AdhereTech, Zenefits, Aidin, and Health Recovery Solutions. He connects the boom in start-ups (and in accelerators like Blueprint Health and StartUp Health, both referenced in the piece) to opportunities and challenges created by the Affordable Care Act. Provisions of the ACA, or ObamaCare, encourage hospitals to reduce readmissions and move from fee-for-service to outcome-based payment, opening up room for cost-saving startups like AdhereTech and IntelligentM. But Matthews argues the law also opens an opportunity for small, web-based health insurers like Zenefits to fill the post-ObamaCare needs of small businesses.

TIME has the article available for subscribers, but StartUp Health published the whole thing on a slideshare on their blog. Keep reading>>

New pediatric PHR from Kinsights actually stands a chance

By: Neil Versel | Aug 9, 2013        

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Neil_Versel_LargeAn emerging company called Kinsights this week launched an online pediatric personal health record for parents to keep track of their children’s medical histories.

I initially rolled my eyes. “Untethered” PHRs—controlled by patients and not directly connected to an institutional EHR—have been an unmitigated failure to date.

As I noted in a February 2013 commentary, they generally don’t fit physician workflow, and physicians generally don’t trust information patients enter. Plus, few patients will even take the time to enter their own data. “It’s like Quicken in the days before online banking let people download all their transactions. You need the interoperability first,” I said.

Further, I wondered why, given the history of patient indifference toward PHRs failures, the White House Office of Science and Technology Policy would back San Francisco-based Kinsights, as it reportedly has. I know some in Washington are bullish on PHRs, and they might have a hope of making it if they follow the Blue Button Plus protocol, which adds structure like the Continuity of Care Document standard to the plain unstructured text of the original Blue Button developed at the Department of Veterans Affairs.

Keep reading>>