May 2, 2018
Cerebrovasular imaging company iSchemaView has received the FDA nod for its latest product the RAPID CTA, a 3D imaging platform for computed tomogrpahy angiography (CTA).
“Our goal is to provide healthcare professionals around the world with the most comprehensive and intuitive suite of imaging solutions possible,” Don Listwin, CEO of iSchemaView, said in a statement. “With new FDA approval and...
March 23, 2018
Correction: A previous version of this story misstated that PhysioWave connects to the user's smartphone. It has been updated to state the system uses a dedicated tablet interface.
University of Stanford spin-out PhysioWave has just received FDA clearance for its pulse wave velocity (PWV) cardiovascular analyzer scale, which measures the stiffness of the vessels transporting blood from the heart...
December 7, 2017
Disposable vitals sensor maker VitalConnect has received a new FDA clearance, lengthening the life of its VitalPatch device from four days to five.
VitalPatch is an FDA-cleared, disposable peel-and-stick health sensor, which continuously monitors eight different vitals (ECG, heart rate, heart rate variability, respiratory rate, skin temperature, posture, and steps, as well as automatic fall...
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...
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....
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...
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...
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....
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...
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...