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 ...

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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 Holdings' AVIM product received FDA breakthrough device designation, accelerating approval and offering speculative optimism for investors. The firm is pre-revenue with significant ...

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 ...

Management will participate in a live fireside chat at 9:50am ET on Tuesday, March 3 rd and will also host one-on-one meetings with investors. The event will be accessible to investors and interested ...

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 ...