赛诺医疗(688108.SH)：子公司产品获美国FDA突破性医疗器械认定

Core Viewpoint - Sino Medical (688108.SH) has received Breakthrough Device Designation from the FDA for its COMETIU self-expanding intracranial drug-coated stent system and COMEX balloon microcatheter, marking a significant milestone in the treatment of intracranial atherosclerotic stenosis [1] Group 1 - The COMETIU system is the first product in the world to receive FDA approval for the treatment of intracranial atherosclerotic stenosis [1] - This designation represents the first breakthrough medical device recognition for a domestic neurointerventional device in China [1]