Hosted on MSN1mon
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 ...
Nasdaq28d
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 ...
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) -- ...
Business Wire1mon
AccurKardia Receives FDA Breakthrough Device Designation for First-of-its-Kind Aortic Valve Stenosis ECG-based AI Screening Software
For a diagnostic tool to qualify for FDA Breakthrough Device Designation, it must provide more effective diagnosis of life-threatening conditions, represent a breakthrough in technology ...
JD Supra27d
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.
STAT18h
Risk of aspiration during surgery added to GLP-1 drug labels
But we have some pretty good clues. Among the possibilities: Newly empowered Republicans could tweak the Medicare drug price ...
Business Wire12d
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 ...
Envoy Medical receives FDA approval to initiate study for hearing device
Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted ...
Nasdaq5d
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 ...
manilatimes5d
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 ...