medtechdive3h
FDA breakthrough device decisions rebound after recent declines
The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
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 ...
Nasdaq23d
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 ...
manilatimes10d
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 ...
Mena FN15d
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 ...
WGN Radio23d
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 ...
Stockhouse23d
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 ...