FDA approves Tongxin Medical’s BrioVAD to enter confirmatory clinical study
August 9, 2025
Source: drugdu
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August 7, BrioHealth Solutions, Inc., a wholly-owned subsidiary of Tongxin Medical in the United States, announced that its independently developed fully magnetically levitated left ventricular assist system, BrioVAD, has been officially approved by the U.S. Food and Drug Administration (FDA) to enter the Pivotal Phase study after successfully completing the Safety Phase of the U.S. INNOVATE clinical trial. The FDA agreed to expand the clinical research centers to 60 and can enroll a total of 780 subjects (including safety phase subjects).
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