Airiver Medical receives FDA breakthrough device status for DCB

The DCB currently remains an investigational device and is not available for sale in the US. "Airiver Medical receives FDA ...
Yahoo

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

Neuralink's Blindsight implant received a special status from the FDA. Elon Musk’s brain chip firm Neuralink has received “breakthrough device” status for an implant aimed at helping blind patients ...
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 ...
STAT

New tests for Alzheimer’s and cancer get FDA’s ‘breakthrough’ status

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. A disease detection chatbot ...
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 ...