Digital health’s busy summer for FDA clearances

By: Brian Dolan | Aug 14, 2012        

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Brian Dolan, Editor, MobiHealthNewsAugust is not yet half over and already the FDA has had a busy summer.

In recent weeks MobiHealthNews reported on the FDA’s de novo clearance of Proteus Digital Health’s intelligent medicine platform and Asthmapolis’ inhaler sensor and companion software. As we noted early last month, the FDA granted 510(k) clearance to a variety of digital health companies in June, including the app-enabled toothbrush from Beam Technolgies, a Bluetooth-enabled blood pressure monitor from iHealth, a surgical sponge management app from Gauss Surgical, and a WiFi-enabled weight scale from China-based ShenZhen. (For more details on these, see our round-up of June 510(k) clearances here.)

In July the agency granted 510(k) clearances to at least a half dozen mobile health companies, including Vignet, Constant Care, Watermark, iHealth, AirStrip Technologies, and iRhythm.

The 510(k) clearances from AirStrip and iRhythm appear to be just another in the series of clearances each company has accumulated for its products. AirStrip already has a handful of 510(k) clearances for its smartphone and tablet based remote patient monitoring (RPM) suite of applications. (The summary details on the latest add-on 510(k) for AirStrip can be viewed here.) Similarly, iRhythm added another clearance for its Zio patch, which has so far bucked the connectivity trend and instead stores heart data that patients transmit to a care center by physically mailing the cardiac monitoring device after wearing it for a period of time.

Vignet, Watermark, and Constant Care each had home health offerings cleared by the FDA in July.

Vignet’s TeleHealth Manager received Class II 510(k) clearance from the FDA last month. The software works with a variety of already cleared external biometric measuring devices, according to the company, including blood pressure devices from A&D and Fora Care, weight scales from A&D and Omron, glucose meters from Entra Health Systems and Fora Care, a pulse oximeter from Nonin Medical, a pedometer from Omron, a thermometer from Fora Care, and a peak flow meter from Vitalograph. The company’s software system collects the physiological data “for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols.” Patients can also view the data “as an aid in maintaining wellness regimens,” the company stated in its FDA filing. Vignet’s iPhone app was the first one to gain certification from interoperability group Continua Health Alliance in March of this year.

Like Vignet’s telehealth offering, Constant Care’s LILAH Home Health Monitoring System is software that collects data from various external biometric devices. Constant Care’s offering has two components, according to the company: The patient-side software that is installed on an Asus EeTop PC or an Acer tablet PC and transmits data to the caretake portal online, and the caregiver-side software online. The system “provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and real-time video conferencing technology,” according to the FDA filing. It works with wired and wireless glucose meters, weight scales blood pressure monitors, medication reminders, and pulse oximeters.

Watermark also received 510(k) clearance for software that acted as a home health hub: Watermark’s Connected Care Mobile Application receives, displays, and transmits patient information “on a retrospective basis” — not in real-time or in emergency situations. The mobile app is designed to work on various platforms, including tablet computers and smartphones, according to the filing. The app helps users collect vital signs data from Bluetooth-enabled medical peripherals, including weight scales, glucose meters, blood pressure devices, and pulse oximeters.

Finally, Andon Health, which counts iHealth Lab as a subsidiary, received clearance for a WiFi-enabled weight scale. Currently, the company only offers a Bluetooth-enabled weight scale through its iHealth subsidiary.

If the agency keeps up this pace in August, we expect another half dozen devices and apps that the FDA considers to be medical devices to announce clearance this time next month.


Precision Health to launch ConditionMatch Mobile ads

By: Brian Dolan | Aug 14, 2012        

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Ubiqi Health Migraine Tracker

Ubiqi Health Migraine Tracker Android App

New York City-based Precision Health Media, an online advertising network that works to help national brands and regional health care providers to “reach diagnosed health audiences”, is launching a new channel for its customers, called ConditionMatch Mobile, to target patients with advertisements via mobile health apps. Precision has signed up AdTheorent, Ubiqi Health, and xAd as its initial partners and app developers. The company also has The Cleveland Clinic signed up as an advertiser looking to reach patients in the Cleveland area through the channel.

“Mobile health is exploding in many ways. Health apps have soared in popularity to track general fitness in addition to actual medical data for review with a doctor,” Bill Jennings, CEO, Precision Health Media stated in a release sent to MobiHealthNews. “Advertisers have followed to reach consumers and patients on the go. We are also seeing local health brands like hospitals and clinics using mobile increasingly to reach patients in their DMAs. Precision Health is offering pharma and other brands a range of opportunities to maximize this growing channel.”

“With ConditionMatch Mobile, we can now deliver a highly relevant mobile audience targeting solution with continuous data supplied to the sponsors,” stated Jacqueline Thong, founder of Ubiqi Health, whose apps reach 10,000 migraine sufferers and other symptom-specific audiences, according to the Precision Health Media release.

Precision Health Media, which was formerly known as Good Health Media, has raised at least $3 million since launching in 2007.

In 2010 the company announced a deal with advertising-supported EMR company Practice Fusion to power the ads presented on that company’s otherwise free electronic medical record offering. At the time Precision Health Media counted Wyeth, J&J, Amgen and Merck among its advertisers. Practice Fusion tells MobiHealthNews that the partnership did not last long and Practice Fusion has been building its own internal advertising department since early 2011.

A similar mobile health advertising network effort, Tomorrow Networks, has a significant lead on Precision Health Media since it launched its health-focused mobile advertising network in October 2011. Tomorrow Networks is a joint venture between Remedy Health Ventures and Physicians Interactive, makers of the popular Skyscape medical app.

Target stores to sell SmartCoach devices this fall

By: Brian Dolan | Aug 13, 2012        

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SmartCoachThis fall Target plans to stock mobile health coaching devices from SmartCoach on its store shelves. Toronto-based MyTrak Health System, a business unit of Medipattern, inked the deal with Target last month, according to the company.

SmartCoach is a wearable mobile health device that aims to differentiate itself with a coaching service that not only tracks activity levels but also monitors progress and encourages users’ success. The companion service to the device also offers analysis tools that help users understand which activities and behaviors impact their health most.

Here’s how the company describes its monitoring technology: “Unlike pedometer based technologies, SMARTCOACH is a small, sophisticated computer that uses patented Smart Body Technology(TM) to sense, analyze, and track body movements in 3-D. SMARTCOACH ties in to each customer’s computer, using advanced interactive graphics to manage lifestyle changes. Each customer can see the steps taken, distance traveled, and energy expended to optimize heart activity and metabolism.”

Medipattern CEO Jeff Collins stated in the announcement that he was pleased to add Target to the company’s retail network, but it appears to be its only other outlet besides direct sales on the company’s own website. Collins did not return an email seeking additional details before deadline.

Noted health economist and Health Populi blogger Jane Sarasohn-Kahn recently pointed out the importance of the Target-Medipattern deal:

“Target, a general retailer of the Big Box variety, is placing a bet on a product category that has been the province of pioneering Quantified Self and early adopting health-minded consumers. Target’s demographic goes well beyond the uber-health conscious: it’s more female, single, and, except for Kohl’s, attracts a greater percentage of households earning over $50K than Kmart or Walmart…” Sarasohn-Kahn wrote. This is an exciting development for whole health: if Target can move SMARTCOACH devices into American households, the category rises for all players including BodyMedia, FitBit, Jawbone, and the many other wearable sensors in and coming onto the market.”

Survey: Many boomers trust doctors to recommend health apps

By: Neil Versel | Aug 13, 2012        

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iPad medicalIt’s long been said that baby boomers are the ones who will challenge the archaic notion that the doctor always knows best. At least when it comes to mobile apps, that does not seem to be the case, a survey suggests.

In a poll of 600 smartphone-using baby boomers by Mitchell Research & Communications, an East Lansing, Mich.-based polling and political consulting firm, 60 percent said a physician was most likely to make them download an app for health or wellness. Family members came in a distant second, at 18 percent, while only 5 percent said friends would be the ones to convince them to download a health app.

Mitchell says that 24 percent of the nation’s 78 million baby boomers own smartphones. The U.S. Census Bureau defines the boomer generation as those born between 1946 and 1964.

According to the survey, conducted in June, 57 percent of boomers with smartphones would download an app providing mobile access to general medical information. But only 48 percent of those queried would get an app for monitoring a specific chronic disease and 47 percent indicated they were likely to download a mobile app to keep track of weight and exercise. Keep reading>>

New NYU center to study advanced wireless technologies in medicine

By: Neil Versel | Aug 13, 2012        

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Ted Rappaport

Ted Rappaport, Founder & Director, NYU Wireless

New York University is the latest institution to open a wireless health research center, though NYU is calling its effort the “first academic research center combining the exploration of advanced wireless technologies, computing and medical applications.”

NYU last week unveiled NYU Wireless, bringing together engineering, computer science and medical faculty and students from the main university, the Polytechnic Institute of NYU (NYU-Poly) and NYU Langone Medical Center.

Founder and Director Ted Rappaport, who holds faculty appointments at NYU-Poly, NYU School of Medicine and the university’s Courant Institute of Mathematical Science, promises that NYU Wireless will be “very different” from other academic wireless health research institutions, such the University of Southern California’s Center for Body Computing, the Harvard-affiliated Center for Connected Health at Partners HealthCare and the UCLA Wireless Health Institute. Notably, NYU Wireless will be looking less at remote patient monitoring than those centers – as well as the non-academic West Wireless Health Institute – and more at the engineering of wireless systems in hospital environments.

Rappaport, who earlier founded centers for studying wireless engineering at Virginia Tech and the University of Texas, had a hand in designing the first wireless pacemaker in the mid-1990s. At NYU, he wants to combine research in engineering and computer science and work with physicians to “bring wireless communications to its Renaissance, including in the medical field,” he tells MobiHealthNews.

“We’re trying to focus on research for medical researchers,” Rappaport says. “We want to bring computational algorithms to the cutting edge of medicine,” he adds.

“We’re finding that a lot of mathematics and circuitry in wireless engineering problems can be applied to medicine, such as in MRI, other types of imaging, real-time data transmissions and so forth,” according to Rappaport.

“NYU has a world-class radiology department and NYU-Poly has excellent wireless engineering,” Rappaport continues. “We are going to try to make advancements in real-time MRI for moving parts of the body, such as the heart and lungs.”

With the help of some of its corporate sponsors, the center also will be looking at wireless data flow within hospitals. “We are motivated to make huge improvements in operating rooms for medical researchers” by looking at wireless signal processing, circuits, antennas and computational methods, Rappaport says. Keep reading>>

Report: Wearable devices a $6B market by 2016

By: Brian Dolan | Aug 9, 2012        

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FitbitIMS Research seems to pile on to growing number of research reports that point to wearable devices as an important trend in digital health: According to IMS by 2016 the “minimum revenue opportunity” for wearable devices will be $6 billion.

IMS Research notes that the current market for wearable devices is concentrated around a small group of products in the healthcare, medical, fitness, and wellness areas. Wearable devices that transmit vital signs and track user performance are found in this group. It includes continuous glucose meters from Abbott and Medtronic as well as activity monitors from Fitbit, Adidas, Nike, Garmin, Polar, and Suunto.

The research firm, however, predicts that the market for wearables will move beyond health and wellness to “include smart watches, smart glasses, sleep sensors, industrial and military heads-up displays and hand-worn terminals.”

“A $6 billion market in 2016 is our most conservative forecast which assumes that the adoption of wearable technology will be limited by factors including lack of suitable technology, poor user compliance and lack of an overall enhanced experience from devices that are wearable as compared to non-wearable products. In our mid-range and upside projections, product introductions such as Google’s Smart Glasses and the rumoured Apple Smart Watch come to fruition and are successful. In addition, an increasingly self-aware consumer seeks more and more data on their health and fitness, leading to even more rapid expansion in the market for wearable technology,” Theo Ahadome, senior analyst at IMS Research stated in a press release.

More on the IMS Research report here.