Tag: FDA Breakthrough device designation
AMF Medical’s Sigi Wearable Insulin Management System Receives FDA Breakthrough Device Designation
AMF Medical announced that its Sigi™ Insulin Management System, for diabetes treatment, has been granted Breakthrough Device Designation by the US Food and Drug...
Biofourmis Receives FDA Breakthrough Device Designation for Novel Digital Therapeutic for Heart Failure
Boston-based virtual care provider Biofourmis dreams of a future where heart failure patients will stay home where they will be remotely monitored via a...