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Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restor

Designation Allows for Expedited Review of Transcatheter Therapy Designed to Improve Left Ventricular Structure and Function in Heart Failure Patients with Reduced Ejection FractionSANTA CLARA, Calif.--(BUSINESS WIRE)--#accucinch--Ancora Heart, Inc., a company developing a novel device-based therapy to address heart...
New York United States Ulrichp Jorde Santa Clara Jeff Closs American Heart Association

T2 Biosystems Receives FDA Breakthrough Device Designation for the T2Lyme PanelMolecular Diagnostic Test for Early Detection of Lyme Disease

T2 Biosystems Receives FDA Breakthrough Device Designation for the T2Lyme PanelMolecular Diagnostic Test for Early Detection of Lyme Disease - read this article along with other careers information, tips and advice on BioSpace
United States John Sperzel Biosystems Inc Us Centers For Disease Drug Administration Exchange Commission

Carthera receives FDA Breakthrough Device Designation for SonoCloud-9 System

Breakthrough Status allows for enhanced interaction with FDA and recognizes SonoCloud system as innovative and promising approach for treatment of recurrent glioblastoma Paris, France, June 22, 2022 – Carthera, a French company that designs and develops SonoCloud, an innovative ultrasound-based medical device to tre...
United States France General Michael Canney Alexandre Carpentier Sandra Thiolli Breakthrough Device Program

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Late-breaking Results Show Efficacy for CCM in Patients With HFpEF

Late-breaking Results Show Efficacy for CCM in Patients With HFpEF Investigators Report Positive Findings From Feasibility Study of CCM in Heart Failure With Preserved Ejection Fraction at the European Society of Cardiology Heart Failure 2022 Congress GlobeNewswire May 23, 2022 MADRID and MARLTON, N.J., May 23, 2022 (GLOBE NEWSWIRE) -- Impulse Dynamics,...
United States Rex Richmond Cecilia Linde Ian Segal Vishu Rao Harriss Currie

Exactech Announces FDA Breakthrough Device Designation for JointMedica's Polymotion® Hip Resurfacing System

Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220517005313/en/ Exactech Announces FDA Breakthrough Device Designation for
United States Jointmedica Polymotion Sharat Kusuma Ronan Treacy Exactech Alteon Terence Smith

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