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 Artificial Heart (TAH) as part of the U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS) on July 9, 2024.
Califf backs increased LDT oversight despite industry opposition
Listen to the article 5 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief: Food and Drug Administration Commissioner