Business Wire

FDA Grants Madorra Breakthrough Device Designation Status for Treatment of Moderate to Severe Vulvovaginal Atrophy

PORTLAND, Ore.--(BUSINESS WIRE)--The FDA has granted Madorra breakthrough device designation for the company’s non-invasive, home-use device for a subset of women experiencing moderate to severe ...
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 ...
Yahoo

Airiver Medical receives FDA breakthrough device status for DCB

Add Yahoo as a preferred source to see more of our stories on Google. The device uses standard balloon dilation for opening the respiratory tract with drug delivery. Credit: SUPAWADEE3625 / ...
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 ...
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 ...