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 ...
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FDA Grants Breakthrough Device Designation For Seastar Medical’S Selective Cytopheretic Device For Adults Undergoing Chronic Dialysis
(MENAFN- GlobeNewsWire - Nasdaq) This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical ...
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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 patient ...
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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 ...
Consumer price index report and Juan Soto's free agency: Morning Rundown
Plus, Donald Trump is set to visit the White House to meet with President Joe Biden for a symbolic meeting to signify a ...
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Heartlung Receives FDA“Breakthrough” Marketing Authorization For First AI To Detect Hidden Heart Disease In CT Scans
The FDA Breakthrough Device designation for AutoChamberTM follows the FDA's recent clearance of HeartLung's AutoBMDTM, an AI-powered opportunistic bone density measurement test that works on any ...
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Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device
The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. CAUTION The fully implanted Acclaim Cochlear Implant is an ...
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FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
Acceptance of the company’s De Novo application follows FDA’s previous granting of Breakthrough Device Designation to DrugSorb-ATR, making it eligible for priority review. The Company ...