FDA

By Jonah Comstock May 16, 2017
Swiss neurogaming company MindMaze has received FDA clearance for its MindMotion Pro platform, a motion capture system similar to the Microsoft Kinect which can be used in rehabilitation of stroke and traumatic injury patients. "In the last few years we’ve launched products at the intersection of the brain and VR," MindMaze CEO Tej Tadi told MobiHealthNews. "What we’ve done today very...
By Jonah Comstock May 11, 2017
Roy J.E.M. Raymann, who, as we reported yesterday, left Apple's sleep team a month ago, has moved to SleepScore Labs, a joint venture between ResMed, Dr. Oz Media, and Pegasus Capital Advisors. He will serve as Vice President of Sleep Science and Scientific Affairs. First announced this year at CES, SleepScore Labs is "currently in the process of examining how people sleep by compiling and...
By Jonah Comstock May 5, 2017
The FDA granted a second 510(k) clearance this week to CareTaker, a Charlottesville, Virginia connected medical device company. CareTaker's device of the same name is a wearable, connected blood pressure and heart rate sensor that originally received clearance this time last year. “CareTaker is a real game changer, allowing physicians to remotely monitor medical-grade continuous blood pressure...
By Jonah Comstock May 1, 2017
AmalgamRx, a newly unstealthed company founded by WellDoc founders Ryan Sysko and Dr. Suzanne Clough, has received FDA clearance for iSage, an insulin titration algorithm. “One of the big challenges with insulin is that it’s scary for patients, they don’t necessarily want to go on it,” Sysko told MobiHealthNews. “So we wanted to find a way to help them optimize their insulin regimen and get to...
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...