本文通过对近年来美国FDA批准的热点领域以及巨头企业的发展历程进行梳理,归纳行业热点领域的发展动向,总结中国的器械相关政策动向,发现美国FDA批准医疗器械数目不断增多,体外诊断、心血管应用领域、医疗AI成为全球三大热点。行业巨头企业重视研发,提前布局热门领域。中国多次发布政策鼓励医疗器械创新,国产优秀医疗器械公司受益。并得出结论,产品创新引领全球医疗器械行业的发展,中国企业需要进一步突破技术壁垒。
<<Objectives:To provide experience for the development of medical device enterprises in China by researching the hotspots of the global medical device industry,the successful path of giant enterprises and equipment-related policies. Methods:Combine the new products approved by the FDA in recent years and the development history of giant enterprises,summarize the development trends of the hotspots in the industry,and summarize the trend of China’s device-related policies. Results:The number of medical devices approved by the FDA is increasing. In vitro diagnostics,cardiovascular applications,and medical AI have become the three hotspots in the world. Industry giants value research and development,and they lay out hot areas in advance. China has repeatedly issued policies to encourage equipment innovation,and domestically produced excellent device companies have benefit. Conclusions:Product innovation leads the development of the global medical device industry,and Chinese companies need to further break through technical barriers.
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