In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.
Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...
toSense’s CoVa Monitoring System 2, a remote patient monitoring necklace that tracks vitals and cardiac fluids, has received a second FDA clearance.
The new clearance will allow the company to update the software to add a new feature that measures stroke volume and cardiac output to the orginal product. The clearance also lets the device connect to a mobile application that allows medical...
The prototype of ToSense's floor pad device, which is about twice the size of a normal weight scale
La Jolla, California-based toSense, the connected vitals signs monitoring device company formerly known as Perminova, has two more multifunction digital health devices in the pipeline to follow up its recently FDA-cleared CoVa Monitoring System. At the BIO event in Philadelphia, cofounder Matt...
In the last two months, the FDA has cleared a number of clinically-focused mobile health devices. Some are first-time clearances for companies that have been waiting on their 510(k) for a while, including a few MobiHealthNews has been keeping an eye on over the years. Others are incremental clearances for slight hardware or algorithm updates. Here's five mobile health clearances that came through...
