BiVACOR Artificial Heart Earns FDA Breakthrough Device Status

BiVACOR artificial heart earns FDA Breakthrough Device status

BiVACOR's magnetic artificial heart gains FDA Breakthrough Device status, promising a revolutionary solution for severe heart failure patients.

Bivacor wins FDA breakthrough nod for titanium total artificial heart

The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.

FDA grants breakthrough device status to BiVACOR's artificial heart

The US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR’s titanium Total Artificial Heart (TAH), as a potential bridge to transplant for the adult population with severe heart failure, where current treatments are insufficient.The post FDA grants breakthrough device status to BiVACOR’s artificial heart appeared first on Medical Device Network.