Heart disease devices lead latest batch of FDA breakthrough nods ...
FDA granted breakthrough device status to several cardiovascular disease treatments, including Puzzle Medical Devices' ModulHeart pump, Alleviant Medical's implant-free heart failure treatment, Vascular Perfusion Solutions' cardiac transport device, and Pedra Technology's tissue perfusion system. Roche also received status for its Elecsys GDF-15 assay, and ShiraTronics and Geistlich Pharma for migraine treatment and cartilage repair, respectively.
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FDA granted breakthrough device status to several cardiovascular disease treatments, including Puzzle Medical Devices' ModulHeart pump, Alleviant Medical's implant-free heart failure treatment, Vascular Perfusion Solutions' cardiac transport device, and Pedra Technology's tissue perfusion system. Roche also received status for its Elecsys GDF-15 assay, and ShiraTronics and Geistlich Pharma for migraine treatment and cartilage repair, respectively.
Berlin Heals' Cardiac Microcurrent Therapy System, an implantable device delivering minimal DC current to the heart, received FDA breakthrough designation. It targets heart failure, showing anti-inflammatory effects and improved cardiac function in preclinical trials.