FDA 510(k)
The app monitors heart rhythms via the smartphone's camera and uses AI to identify irregularities.
Correction: Thanks to an eagle-eyed reader, this story has been updated to remove the claim that Dip.
At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States.
Cambridge, Massachusetts-based sensor maker MC10, known for its flexible and stretchable electronics, has received its first FDA 510(k) clearance for the BioStamp nPoint system.
Smart thermometer and connected health company Kinsa has launched a new wireless version of its device, called Kinsa QuickCare, after securing FDA clearance last month.
Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month.
Over the past year, MobiHealthNews has covered 36 devices that received clearance from the Food and Drug Administration.
China-based Viatom Technologies has received FDA 510(k) clearance for Checkme Pro, a connected medical device that tracks a number of vital signs, according to Medgadget.
Philosys has received an FDA 510(k) clearance for the Android version of its smart glucometer companion app, called Gmate Smart.
Visible Patient, a French company that makes 3D models of human organs to assist surgeons, has received FDA 510(k) clearance for its VP Planning Software Suite.