FDA

By Heather Mack April 18, 2017
Dublin, Ohio-based Monitored Therapeutics, Inc. (MTI) has received FDA 510(k) clearance for its connected spirometer, GoSpiro. The device, which calculates diagnostic-quality air capacity measurement, was designed specifically for use in a non-clinical setting. As calculations are performed inside the device, GoSpiro can work with any smartphone, tablet or computer without the need for separate...
By Jonah Comstock April 13, 2017
Nanobiosym, the Cambridge, Massachusetts-based digital health company whose Gene-RADAR scanner won the Nokia Sensing X Prize a few years ago, has been granted Emergency Use Authorization (EUA) from the FDA for its Zika Virus Test.  EUA is a special clearance pathway the FDA uses for devices that address an immediate public health crisis like Zika. Devices authorized under EUA aren’t cleared or...
By Heather Mack April 12, 2017
Madison, Wisconsin-based EnsoData has received FDA clearance for its sleep analysis software called EnsoSleep, which uses machine learning to analyze sleep quality and aide in diagnosis of sleep or respiratory-related sleep disorders. EnsoSleep, which began as a research effort between founders Chris Fernandez and Sam Rusk while they were students at the University of Wisconsin Madison, is...
By Jonah Comstock April 10, 2017
Chinese medical supply company Shenzen-Kingyield has received FDA 510(k) clearance for a Bluetooth-connected blood pressure monitor. The device is worn on the wrist and sends data to a smartphone for archiving or analysis, according to the clearance document, and the device has been cleared for over the counter sales. The company makes a variety of blood pressure monitors, blood glucose monitors...
By Heather Mack April 7, 2017
In a true first, the Food and Drug Administration is allowing 23andMe to sell its direct-to-consumer genetic test kits that provide information about an individual’s risk to certain diseases such as Alzheimer’s or Parkinson’s disease. 23andMe’s $199 genetic tests are available with the FDA’s blessing nearly three and a half years after the agency first ordered 23andMe to immediately stop selling...
By Jonah Comstock March 31, 2017
The health subcommittee of the House Energy and Commerce committee met this week to question Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, about the medical device user fee amendments (MDUFA). MDUFA is an agreement between the FDA and industry in which the FDA agrees to do certain things in return for industry groups supporting the agency’s work by paying fees...
By Heather Mack March 31, 2017
In the first quarter of 2017, we tracked seven digital health-related FDA clearances. While the list isn’t long, it’s varied and relatively novel – from app and device integrations for diabetes treatment to a vest that maps cardiac rhythms. The beginning of this year also rang in some big changes, as the Trump Administration took root and nominated Dr. Scott Gottlieb as FDA deputy commissioner....
By Jonah Comstock March 15, 2017
The FDA is considering the creation of an Office of Patient Affairs, focused on soliciting the perspectives of patients and taking those insights into account as it sets regulatory policy. The move grows out of a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in 2012. FDASIA instructs the HHS secretary to  "develop and...
By Jonah Comstock March 13, 2017
Telemedicine company Teladoc has added a new position, executive vice president and chief revenue officer, and has tapped Peter Nieves for the role. Nieves was previously the EVP of employer markets at Optum, where he built that business up to be worth more than $1 billion according to a release from Teladoc. “Successfully advancing to the next level is always reliant on having the right people...
By Jonah Comstock March 13, 2017
With previous rumored Trump picks to lead the FDA, we’ve had to rely on speculation to gauge their approach to mobile and digital health. Not so with former FDA deputy commissioner Dr. Scott Gottlieb, Trump’s final pick as of Friday.  Gottlieb, who will still have to be confirmed by the Senate, has made his feelings about mobile health regulation very clear. In 2014, he co-authored a piece for...