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) -- ...
Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device
The Acclaim® Fully ImplantedCochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients ...
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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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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 ...
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Spectral Medical Provides October Tigris Trial Update
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic ...
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Pulse Biosciences, Inc. (PLSE) Q3 2024 Earnings Call Transcript
The Cardiac Surgical System also received U.S. FDA breakthrough device designation for the treatment of AF and was enrolled in FDA's TAP program, which is short for Total Product Life Cycle ...
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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 anticipates 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 ...