DANVERS, Mass., Dec. 07, 2016 (GLOBE NEWSWIRE) -- Abiomed, Inc. (ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced it has expanded its U.S. Food and ...

Dublin, Nov. 21, 2024 (GLOBE NEWSWIRE) -- The "The FDA (Food and Drug Administration) Drug Approval Process Training Course" conference has been added to ResearchAndMarkets.com's offering. The US is ...

Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...

MARTINEZ, Calif.--(BUSINESS WIRE)--Today, ExThera announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for ExThera’s OncoBind ...

ST. LOUIS — A newly FDA-approved procedure allows patients to regrow their own knee cartilage using autologous cell implantation. The treatment, known as MACI (Matrix Autologous Chondrocyte ...

After claiming its approval in Europe earlier this year, Abbott has secured the FDA’s go-ahead for its Volt pulsed field ablation system for irregular heart rhythms, a step forward in an | With the U.

IRVINE, Calif. - InMode Ltd . (NASDAQ: NASDAQ:INMD), a prominent global provider of medical technology, announced today that the U.S. Food and Drug Administration (FDA) has granted an additional 510(k ...

Abbott’s Volt pulsed field ablation system — for the treatment of atrial fibrillation. The Volt system delivers high-energy electrical pulses to targeted areas of the heart to disrupt abnormal rhythms ...

The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.

BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) announced Thursday that the U.S. Food and Drug Administration has approved its iohexol injection (300 mg Iodine/mL), the first generic ...

Novo Nordisk's Wegovy pill is the first oral GLP-1 receptor agonist approved for weight management, offering a new treatment ...