FDA clearance

By Dave Muoio July 11, 2018
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced that it has received FDA 510(k) clearance for an algorithm that helps physicians quantify a patient’s coronary artery calcification. From a ECG-gated computed tomography (CT) scan, the Coronary Calcium Scoring algorithm automatically calculates a calcification rating equivalent to those derived using the Agatston...
By MobiHealthNews July 5, 2018
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.   In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the...
By Laura Lovett June 22, 2018
Children with Type 1 diabetes will now have access to the Medtronic MiniMed 670G, a hybrid closed-loop system insulin delivery system, following the FDA’s decision to expand the product approval for a younger demographic.  In 2016 the device became the first FDA-approved continuous glucose monitoring system that controls automated insulin delivery via a hybrid closed loop system. But at that time...
By Laura Lovett 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...
By Laura Lovett 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...
By Jonah Comstock 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...
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...