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 ...

Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. The device is an atrio-ventricular interval modulation therapy, meaning it uses a ...

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 ...

A new study from the University of Chicago taps an ingredient most often used in the lithium-ion batteries that power our ...

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 ...

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 ...

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 ...