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U.S. and Chinese experts demand global standards for heart pumps to ensure safety and accurate evaluation.
Industry leaders from the U.S. and China are urging global standards for left ventricular assist devices (LVADs) due to inconsistent terminology and misleading claims, such as labeling hydrodynamic bearing pumps as fully magnetically levitated.
Chinese firms like BrioHealth Technologies have gained FDA approval for clinical trials of advanced magnetically levitated pumps, challenging U.S. dominance.
Experts warn these ambiguities hinder accurate evaluation, complicate clinical decisions, and risk patient safety.
A recent symposium in Vienna highlighted the need for transparent, unified definitions and performance criteria.
The next International Society for Mechanical Circulatory Support meeting, expected in China, may advance collaborative efforts.
Los expertos estadounidenses y chinos exigen estándares globales para las bombas cardiacas para garantizar la seguridad y la evaluación precisa.