Envoy Medical, Inc: Envoy Medical Reports Third Quarter 2024 Results and Other Exciting Events
Envoy Medical®, Inc. ("Envoy Medical") (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing devices, today ...
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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 ...
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The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing ... site ...
Aethlon Medical, Inc.: Aethlon Medical Reaches Key Milestone with Enrollment of the First Patient in (FPI) Its Hemopurifier Cancer Trial in Australia
Patient Enrolled at the Cancer Clinical Trial Unit, CALHN, Royal Adelaide Hospital Aethlon's Trial is a Safety, Feasibility, and Dose Finding Study of the Hemopurifier® ...
Spectral Medical Announces Third Quarter Results and Provides Corporate Update
Detailed price information for Spectral Medical Inc (EDT-T) from The Globe and Mail including charting and trades.
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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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Novo asks FDA to bar compounders from making Ozempic copies
Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex ...
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Invenio Imaging Receives FDA Breakthrough Device
SANTA CLARA , Calif., Oct. 30, 2024 /PRNewswire/ -- Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), announced today that the U.S Food and Drug ...
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Medical device innovations named among best inventions of 2024
You can read more about these diagnostic and device innovations — plus others in a wide range of categories — at Time. DeviceTalks is a conversation among medical technology leaders. It's events, ...
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FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time
July 2024, Paper: "The Food and Drug Administration’s (FDA’s) breakthrough therapy designation (BTD) program was created to increase patient access to safe and effective therapies by supporting the ...
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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 review. The Company ...