The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to BiVACOR’s total artificial heart (BTAH), greenlighting the way for an early feasibility study in ...

HOUSTON — In a groundbreaking move, the FDA has approved the second phase of clinical trials for the BiVACOR mechanical heart, a device that could potentially make human heart transplants a thing of ...

The BiVACOR Total Artificial Heart (TAH) is a compact, titanium-constructed device about the size of a fist. Despite its small stature, it packs a powerful punch. It can pump blood at a rate of 12 ...

HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR, Inc., a clinical-stage medical technology company developing a total artificial heart (TAH), today announced that Raymond W. Cohen has been ...

Houston, Texas, July 25, 2024 – The Texas Heart Institute (THI) and BiVACOR ®, a clinical-stage medical device company, announced today the successful first-in-human implantation of the BiVACOR Total ...

HUNTINGTON BEACH, Calif. & HOUSTON & GOLD COAST, Australia--(BUSINESS WIRE)--BiVACOR, Inc., a clinical-stage medical technology company developing a total artificial heart (TAH), today announced that ...

As part of a five-patient FDA Early Feasibility Study, BiVACOR TAH successfully bridges all five patients to a donor heart transplant. Data supports the expansion of the Early Feasibility Study to 20 ...

A 58-year-old man in the United States is the first person in the world to have had his failing heart replaced with a temporary, titanium blood-pumper. The metal organ looks like it was made for the ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min Bivacor is also gearing up for ...

Milestone Deepens Strategic Partnership with FDA Following Breakthrough Device Designation BiVACOR, Inc., a clinical-stage medical device company developing the world’s first titanium Total Artificial ...

The MarketWatch News Department was not involved in the creation of this content. BiVACOR Total Artificial Heart Successfully Implanted in Five Patients as Part of FDA Early Feasibility Study; FDA ...