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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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Chinese artificial heart pump gains FDA approval for US clinical trials

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

  1. SCMP — Tech TIER_1 English(EN) · Holly Chik ·

    How a ‘Chinese heart’ could get US blood pumping despite biotech decoupling

    A “Chinese heart” could be helping to save lives in the United States despite efforts to decouple the two countries’ biotechnology sectors as a result of rising political tensions. The fully magnetically levitated pump, which is slightly bigger than a table tennis ball, has been …