健世科技-B(09877.HK)經導管三尖瓣置換系統產品入選美國產品全生命周期諮詢計劃試點
健世科技-B(09877.HK)公布,其自主研發的經導管三尖瓣置換系統產品已入選美國食品及藥物管理局(FDA)的產品全生命周期諮詢計劃(TAP)試點。
TAP旨在通過促進FDA與醫療器械製造商之間早期、頻繁及戰略性的溝通,以確保美國患者能夠於未來幾年內在全球範圍率先獲得高品質、安全、有效及創新的醫療器械。截至9月8日,FDA在TAP試點中納入了9款器械。
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