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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 ...
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FDA grants breakthrough designation to Roivios’s renal assist device
Roivios has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its JuxtaFlow renal assist device (RAD), designed to provide kidney protection for patients ...
Business Insider1mon
Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide
The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis ...
MarketWatch1mon
Ultragenyx Pharmaceutical's Bone Disease Drug Gets FDA's Breakthrough Therapy Designation
The breakthrough therapy designation allows the company to speed up the development and review of drugs which can help treat serious conditions. The FDA's decision as based on preliminary clinical ...
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 ...
Morningstar1mon
Biogen Gets FDA Breakthrough Designation for Kidney-Transplant Drug
Biogen said it won Food and Drug Administration breakthrough-therapy designation for its proposed treatment for a major cause of kidney-transplant failure. The Cambridge, Mass., biotechnology ...
Yahoo Finance1mon
RARE's Bone Disorder Drug Gets FDA's Breakthrough Therapy Tag
Ultragenyx Pharmaceutical RARE announced that the FDA has granted the Breakthrough Therapy designation to its investigational candidate, setrusumab (UX143), as a treatment to reduce the risk of ...
MarketWatch1mon
Mirum Pharmaceuticals' Volixibat Gets Breakthrough Therapy Designation from FDA
Mirum Pharmaceuticals's volixibat was granted breakthrough therapy designation by the Food and Drug Administration as a potential treatment for cholestatic pruritus for those with primary biliary ...
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) -- ...
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FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
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 ...