The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) ...

The US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR’s titanium Total Artificial ...

The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically ...

The FDA has granted a breakthrough device designation to the BiVACOR Total Artificial Heart. Made of titanium, the device uses a magnetically levitated rotor to pump blood in adult patients with ...

Clinical-stage company earns key regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use. HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR, a clinical ...

The New York Times reported last week that Dr. Robert K. Jarvik, who led the development of the first artificial heart, ...

On July 26 of last year, we reported that the first maglev artificial heart made by the BiVACOR company had been implanted inside the body of a patient at the Texas Heart Institute. The goal of ...

“The entire BiVACOR team is deeply grateful to the patient and his family for placing their trust in our Total Artificial Heart,” he said in the statement. “Their bravery will pave the way ...

BiVacor announced today that it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system.