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Bivacor pumped by FDA IDE approval for total artificial heart study

“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.

FDA approval for BiVACOR s artificial heart study paves further paths for heart tech innovation

BiVACOR, Inc., a pioneer in the development of total artificial hearts, has achieved a significant milestone with the US Food and Drug Administration (FDA).

US FDA Grants the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study

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

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