The FDA says approval for medical devices now requires meeting certain cybersecurity standards issued in the omnibus spending bill signed in December 2022
The Food and Drug Administration affirmed Wednesday that medical device manufacturers must now prove their products meet certain …
Fitbit receives FDA clearance for passive heart rhythm monitoring to detect signs of atrial fibrillation (AFib) and will roll out the feature in the US soon
The Food and Drug Administration has given Fitbit the green light to monitor users' heart rhythms in the background.
Tandem Diabetes Care says one of its apps got FDA clearance to program insulin delivery for the company's pump, the first such app to receive approval
t:slim X2 insulin pump users can use the app to program doses rather than the pump itself — The Food and Drug Administration cleared …
The FDA authorizes AppliedVR's EaseVRx as a prescription VR treatment for chronic lower back pain in adults
It joins a handful of other digital therapeutics — The Food and Drug Administration authorized a virtual reality system as a prescription treatment for chronic back pain, the agency announced today....
AliveCor Kardiaband EKG reader gets FDA approval as the first medical device accessory for the Apple Watch
The Food and Drug Administration has just cleared AliveCor's Kardiaband EKG reader as the first medical device accessory for the Apple Watch. — Europe has been able to use …
FDA publishes new cybersecurity guidelines for securing medical devices, but the recommendations lack enforceability
The Food and Drug Administration has finalized guidance … Tweets: Subrahmanyam KVJ / @sub8u : Sign you are in 2016. You get cybersecurity guidelines from...the FDA...about connected medical devices! h...