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After FDA’s mobile medical apps final guidance, what’s next?

By Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on mHealth, I feel the urge to [...] Read More...

Published Tue, Mar 03 2013 8:30 AM by mobihealthnews

Filed under: Uncategorized, iPhone medical apps, FDA mobile health, mobile medical apps, mobile medical devices, 510K, mHealth regulations, FDA draft guidance, mHealth House Hearings, Epstein Becker, FDA final guidance, MMA regulations

Asthmapolis secures FDA clearance for inhaler sensor

Asthmapolis announced today that the US Food and Drug Administration (FDA) has granted its asthma sensor and companion software 510(k) clearance. The company’s device is a sensor that sits atop (most) inhalers used by patients who have asthma or COPD. The sensor transmits data to a companion app on the user’s mobile phone every time [...] Read More...

Published Wed, Jul 07 2012 9:24 AM by mobihealthnews

Filed under: Uncategorized, COPD, FDA mobile health, wireless medical devices, chronic condition management, Qualcomm 2net, FDA 510(k) clearance, Asthmapolis, mobile medical devices, Dignity Health, asthma management, connected inhaler, iPhone asthma apps

iHealth to launch Bluetooth wrist-worn blood pressure monitor next

iHealth Lab, a subsidiary of China-based Andon Health, just received 510(k) clearance from the FDA for a wrist-worn, Bluetooth-enabled blood pressure monitor called the iHealth BP7 Wireless Blood Pressure Wrist Monitor that will connect with iPhones, iPads, and iPod touch devices. The original iOS-enabled iHealth blood pressure cuff, which the company launched at the Consumer Electronics [...] Read More...

Published Mon, Jul 07 2012 3:05 PM by mobihealthnews

Filed under: Uncategorized, FDA mobile health, Withings weight scale, iHealth weight scale, iHealth wrist worn blood pressure, iHealth Bluetooth blood pressure, Gauss Surgical, ShenZhen Healthcare WiFi Body Scale, 510(k) mobile health apps, iHealth Blood Pressure Dock, iHealth Lab

How Congress almost delayed the FDA’s mobile medical app guidance

Much has been written in the past few weeks about Congress’ efforts to put its mark on the FDA’s regulation of mobile medical apps. I was curious how this issue of 510(k) clearance for mobile apps became a topic of interest for Congress. The FDA published its draft guidance a year ago now. After hundreds [...] Read More...

Published Thu, Jul 07 2012 8:39 AM by mobihealthnews

Filed under: Uncategorized, iPhone health apps, iPhone medical apps, FDA mobile health, iPad health apps, iPad medical apps, FDA mobile medical apps, FDA medical apps, FDA mobile draft guidance

DuoFertility commercially launches in US for $795

This past December the FDA cleared DuoFertility, a basal body temperature thermometer sensor developed by Cambridge Temperature Concepts. The device, which is intended for use in measuring and recording basal body temperature as an aid in ovulation prediction to aid in conception, has been available in the UK for some time but only became commercially [...] Read More...

Published Thu, Apr 04 2012 5:06 AM by mobihealthnews

Filed under: Uncategorized, FDA mobile health, wireless medical sensors, DuoFertility, Cambridge Temperature Concepts, FDA wireless health, in-vitro fertilization

FDA clears Smartheart mobile ECG device

As we reported in our Mobile Health: State of the Industry Q1 2012 report, the FDA cleared SHL Telemedicine’s Smartheart device, which is meant to be used by consumers to send their own 12 lead ECG data to a physician from the device. Smartheart transmits the ECG data to the user’s mobile phone via Bluetooth. According [...] Read More...

Published Tue, Apr 04 2012 7:07 AM by mobihealthnews

Filed under: Uncategorized, FDA mobile health, AliveCor iPhoneECG, mobile health FDA clearances, SHL Telemedicine, AliveCor iCard ECG, Smartheart mobile ECG

FDA mulls the role of screening apps, devices

This week the US Food and Drug Administration (FDA) is holding a hearing about using innovative technologies and other mechanisms to expand the number of medications that can administered over the counter. A report in the San Diego Union Tribune recognizes that some of the innovations that the FDA has in mind are mobile health [...] Read More...

Published Tue, Mar 03 2012 7:45 AM by mobihealthnews

Filed under: Uncategorized, FDA mobile health, mobile health regulation, mobile medical apps, screening devices, pharmacist, screening apps

Independa adds Telcare’s cellular glucometer

Senior care company Independa has inked a deal with Telcare to add its cellular-enabled glucose meter to its remote management services for older people. Telcare’s meter received clearance from the FDA last August, making it the first meter with cellular embedded. The Telcare BGM device sends the glucose readings to the company’s central server, which then [...] Read More...

Published Mon, Mar 03 2012 9:41 PM by mobihealthnews

Filed under: Uncategorized, FDA mobile health, mobile diabetes management, Independa, Healthrageous, Telcare, iPhone diabetes app, Telcare BGM, MagnaCare, MyTelcare Diabetes Pal iPhone app, smartphone medical app

12 trends for mobile health in 2012

Last week MobiHealthNews hosted its first webinar of 2012. During my presentation I shared my 12 trends for 2012. Our co-presenter, Aaron Kaufman from Kony Healthcare Solutions also shared his take on the year ahead. Check out the complimentary, hour-long webinar on demand right here. 1.) The Adoption of Smartphones and Tablets. This is by far [...] Read More...

Published Tue, Feb 02 2012 7:25 AM by mobihealthnews

Filed under: Uncategorized, HIPAA mobile health, FDA mobile health, mobile health, WellDoc, mobile health clinical trials, mobile health efficacy, Nielsen

Duofertility wireless sensor receives FDA clearance

Late last year the US Food and Drug Administration (FDA) cleared Duofertility, a computerized basal body temperature thermometer developed by Cambridge Temperature Concepts, with a 510(K). Cambridge Temperature Concepts developed the device, which is intended for use in measuring and recording basal body temperature as an aid in ovulation prediction to aid in conception, according [...] Read More...

Published Fri, Jan 01 2012 11:35 AM by mobihealthnews

Filed under: Uncategorized, FDA mobile health, wireless medical sensors, ivf, FDA 510(K) clearances, FDA cleared medical devices, DuoFertility, wireless health regulation, conception

FDA clears Withings iPhone blood pressure cuff

Withings announced this week that they’ve received FDA clearance for their iOS-compatible blood pressure monitor, allowing for its immediate availability in the US for a $129.99 retail price. The release marks the first time an FDA-approved BP cuff includes direct connectivity with an iOS device. First announced at CES this year, the monitor runs on [...] Read More...

Published Mon, Jun 06 2011 11:12 AM by mobihealthnews

Filed under: Uncategorized, Withings blood pressure, FDA mobile health, FDA 510(k)

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