The FDA’s drive to accelerate access to new medical device technologies continues, with a new product from 3i Diagnostics receiving a Breakthrough Device Designation.
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Elon Musk’s Neuralink brain chip receives FDA’s ‘breakthrough device’ status — and could help blind people see againElon Musk’s brain chip firm Neuralink has received “breakthrough ... from the US Food and Drug Administration to participate in the voluntary program. It is one of 58 devices to receive ...
SI-BONE, Inc. SIBN announced first-in-patient procedures with the FDA-designated breakthrough device, iFuse TORQ TNT Implant System (TNT), on Thursday. TNT received the FDA’s 510(k) clearance ...
FDA-designated breakthrough devices are devices that FDA has determined provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorde FDA ...
DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences ...
Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an email reviewed by STAT and sent out to FDA device staff on Tuesday afternoon.
Dassault Systèmes Collaboration Yields Breakthrough Guide for Using Virtual Twins in Clinical Trials
Dassault Systèmes (Euronext Paris: FR0014003TT8, DSY.PA) today announced the availability of the world’s first guide for the ...
Detailed price information for Seastar Medical Hldg Corp (ICU-Q) from The Globe and Mail including charting and trades.
“Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss ...
“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to save lives and improve ...
"This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA's continued recognition of the SCD's potential to save lives and improve patient ...
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