Orchestra BioMed has announced that the FDA has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, aimed at treating over 7.7 million U.S. patients ...
Breakthrough Device Designation (“BDD”) applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk BDD also encompasses ...
Orchestra BioMed holds two best-in-class medical device therapies targeting large markets, with strong partnerships and equity investments from Medtronic and Terumo. Both AVIM Therapy and Virtue SAB ...
FDA has granted breakthrough device designation (BDD) for Orchestra BioMed's atrioventricular interval modulation (AVIM) therapy. Specifically, the designation is for an implantable device designed to ...
Orchestra BioMed Holdings, Inc. announced significant regulatory advancements and financial results for the first quarter of 2025, including the recipient of FDA Breakthrough Device Designation for ...
NEW HOPE, Pa., July 13, 2020 (GLOBE NEWSWIRE) -- Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products ...
David Pacitti is currently the President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers; formerly Division Vice President of U.S. Commercial Operations, Sales, ...
Orchestra BioMed Holdings shares rallied premarket after the maker of medical devices said a blood-pressure mechanism received breakthrough status from the U.S. Food and Drug Administration, allowing ...
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