Group 1 - The core viewpoint is that Sino Medical's COMETIU self-expanding intracranial drug-coated stent system and COMEX balloon microcatheter have received breakthrough medical device designation from the FDA, marking them as the first globally recognized products for treating intracranial atherosclerotic stenosis (ICAS) [1] - These products are expected to benefit millions of stroke patients worldwide by promoting vascular endothelial healing and reducing postoperative risks without neurotoxicity [1] Group 2 - The FDA designation provides a series of "accelerated privileges," allowing the products to capture market share earlier and establish a competitive advantage [3] - China's medical device exports are projected to reach 140.308 billion yuan in 2024, with a year-on-year growth of 7.3%, and 69.26 billion yuan in the first quarter of 2025, growing by 5.03% year-on-year [3] - Future investments in R&D by Chinese medical device companies are expected to enhance product technology and quality to meet international high-end market demands [3] - Policy support from the Chinese government aims to expand the export sales certification scope and facilitate the internationalization of domestic medical products [3] - Major companies in the medical device sector are anticipated to see a rapid increase in overseas revenue share, with significant growth in international business expected by 2025 [3]