New App Store policy requires medical device disclosures for some health apps

Starting today, some App Store apps must declare whether they are regulated medical devices in the US, UK, and Europe. Here ...
Business Wire

FDA Grants Breakthrough Device Status to Toku’s Patented Cardiovascular Risk AI (CLAiR) Platform

Toku’s AI (CLAiR) technology platform has received FDA Breakthrough Device status, and if cleared by the FDA will deliver real-time cardiovascular disease (CVD) risk assessments through routine eye ...
Healio

Coronary implant for treatment of CAD granted breakthrough device status by FDA

Please provide your email address to receive an email when new articles are posted on . The FDA granted breakthrough device designation status to a coronary implant for patients with CAD. In a ...
Yahoo

Elon Musk’s Neuralink brain chip receives FDA’s ‘breakthrough device’ status — and could help blind people see again

Add Yahoo as a preferred source to see more of our stories on Google. Neuralink's Blindsight implant received a special status from the FDA. Elon Musk’s brain chip firm Neuralink has received ...
Morningstar

Amplifi Vascular Gains FDA Breakthrough Device Status & CMS Category B

ST. LOUIS, Jan. 13, 2026 /PRNewswire/ -- Amplifi Vascular, Inc., has been granted Breakthrough Device Designation and Category B assignment from the Centers for Medicare & Medicaid Services (CMS) for ...
The American Journal of Managed Care

FDA Gives Breakthrough Device Status to CLAiR Platform Assessing CVD Risk Through Eye Exams

Toku’s platform aims to deliver real-time cardiovascular disease (CVD) risk assessments using routine eye exams. The FDA has granted breakthrough device status to Toku’s cardiovascular risk artificial ...
Medscape

No-Implant Shunt Wins FDA Breakthrough Status for Heart Failure

Texas-based medical device company Alleviant has received a breakthrough device status from the US Food and Drug Administration (FDA) for its new no-implant atrial shunt for heart failure and will ...
Healio

AI algorithm for detection of cardiac amyloidosis gains FDA breakthrough device status

Please provide your email address to receive an email when new articles are posted on . An artificial intelligence-guided algorithm to identify cardiac amyloidosis received a breakthrough device ...
Drinks

Signify gets grant for system for presenting status of lighting device on multiple devices

Signify has been granted a patent for a system that receives and presents status information of a lighting device on user devices based on privacy settings. The technology allows for tailored ...