The US Food and Drug Administration (FDA) has given Breakthrough Device Designation to Orchestra BioMed for its atrioventricular interval modulation (AVIM) therapy for patients with uncontrolled ...
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 ...
The Food and Drug Administration on Monday granted its first approval for a pacemaker-like device for the brain to ease symptoms of Parkinson's disease, which affects nearly 1 million people in the ...
Robert Kowal, MD, tells MD+DI how he became involved with the development of Medtronic's Micra leadless pacemaker.
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