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 plan for the regulatory world after FDA publishes its final guidance. FDA testified the...
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 the inhaler is used. The app can then track the time and...
iHealth's original Blood Pressure Cuff for iOS users
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...
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 The FDA published its draft guidance a year ago now.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 of companies weighed in with their thoughts on the document, the industry widely expects a...
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 available in the United States this week....
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 to the company, "the Smartheart is a personal, hand-held battery powered, 12...
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 apps and devices.
"FDA is aware that industry is developing new...
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 sends it to Independa's cloud-based...
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 the most obvious trend because it has been so steady...
The Duofertility Reader
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,...
