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Elon Musk’s Neuralink brain chip receives FDA’s ‘breakthrough device’ status — and could help blind people see again
Elon 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 ...
pharmaphorum6y
FDA Breakthrough Device Designation for blood infection test
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.
pharmaphorum1y
Breakthrough Device Designation
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 ...
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
Nasdaq1mon
SIBN Stock Up After First-In-Patient Use of FDA Breakthrough Device
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 ...
JD Supra29d
Medicare Coverage: CMS Finalizes New Pathway for Breakthrough Devices
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.
STAT22d
Michelle Tarver to lead FDA medical device center
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.
Business Wire14d
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 ...
SeaStar Medical to Distribute QUELIMMUNE Directly to Hospital Customers
Detailed price information for Seastar Medical Hldg Corp (ICU-Q) from The Globe and Mail including charting and trades.
Morningstar12d
Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device
“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 ...
Nasdaq7d
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
“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 ...
manilatimes7d
FDA Grants Breakthrough Device Designation for SeaStar Medical's Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
"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 ...