FDA clearance

By Jonah Comstock November 7, 2017
FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an approach reminiscent of the...
By MobiHealthNews October 20, 2017
Led by a new commissioner in Dr. Scott Gottlieb, the FDA had a busy few months with a handful of digital and mobile technologies getting cleared in the third quarter of 2017. Consumer-focused diabetes and pain management offerings were prominent, but but by and large the clearances hit a multitude of clinical concerns and, of note, even included the first software-only digital therapeutic....
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 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 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 December 20, 2016
The FDA has officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions -- without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.  "The FDA works hard...
By Heather Mack October 18, 2016
Redwood City, California-based biotricity, which is working on a biometric remote monitoring solution, has received FDA clearance for the software component of their product. The company’s first offering, which is slated for market launch later this year or early next year, is bioflux – a remote cardiac monitoring solution that includes a wearable heart monitor (to be worn on the torso) that uses...
By Jonah Comstock August 23, 2016
The FDA has granted de novo clearance to two concussion assessment software products from ImPACT Applications. The Pittsburgh-based company developed its original software in the 90s for computers, though the clearance also includes ImPACT Pediatric, a newer version of the tests for children that runs on an iPad. "ImPACT's FDA clearance is a huge step forward for the industry, for athletes and...
By Brian Dolan June 29, 2016
Redwood City, California-based smartphone-connected breast pump startup Naya Health has received FDA clearance for its first pump system. Naya Health's device is called The Smart Pump, and it uses a hydraulic system instead of air to collect breastmilk. As a result, the pump is more comfortable and quieter, according to the company.  Some data from the system, including how often a mother pumps,...
By Jonah Comstock February 10, 2016
BioGaming, an Israel-based startup, has received FDA clearance for its YuGo Microsoft Kinect-based physical therapy system. Calls to the company for comment went unanswered and its website appears to be down.  Physiotherapists can use the system to create personalized gameified routines for patients which patients can then complete at home using an Xbox or a computer connected to a Kinect device...