Chinese artificial heart pump gains FDA approval for US clinical trials

The BrioVAD, a Chinese-developed artificial heart pump, has received FDA approval for clinical trials in the United States. This marks the first time an active implantable medical device from China has been approved for such trials in the US. The device, which is smaller than a table tennis ball, has already been implanted in over 100 patients in the US as part of a trial to assess its safety and efficacy against the currently dominant HeartMate 3. AI

RANK_REASON Product approval for clinical trials in a major market. [lever_c_demoted from significant: ic=1 ai=0.0]

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• Abbott
• BrioVAD
• China
• United States
• Food and Drug Administration

• product
• policy

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