AI医疗器械爆发前夜：医学影像与诊断设备引领千亿级市场变革 头豹词条报告系列

Investment Rating - The report indicates a positive outlook for the AI medical device industry, highlighting its potential for significant growth and market expansion due to technological advancements and regulatory support [1]. Core Insights - The AI medical device industry is on the verge of a breakthrough, driven by the commercialization of artificial intelligence technology and increasing regulatory approvals for various products [1][30]. - The market size of AI medical devices has grown from 1.25 billion RMB in 2019 to 4.37 billion RMB in 2023, with a compound annual growth rate (CAGR) of 143.33% [30]. - The industry is expected to continue expanding, with projections indicating a market size of 52.49 billion RMB by 2028, reflecting a CAGR of 68.58% [30]. Industry Definition - AI medical devices are defined as medical devices that utilize medical device data and artificial intelligence technology to achieve their intended medical purposes [2]. Industry Classification - AI medical devices can be classified based on their intended use into two categories: decision-supporting and non-decision-supporting devices [4][6]. Industry Characteristics - The AI medical device industry is characterized by its wide application across various medical fields, a diverse range of participating companies, and a steady increase in the number of approved Class III medical device registrations [8]. - The number of approved Class III medical devices has shown consistent growth, with 81 AI medical devices approved by the end of 2023, marking a significant increase from previous years [11][18]. Development History - The AI medical device industry has evolved through three major phases, with significant milestones including the first AI medical device approval in 2018 and the subsequent commercialization of deep learning-based products starting in 2020 [12][15]. Industry Chain Analysis - The industry chain consists of upstream hardware suppliers, midstream AI medical device manufacturers, and downstream application terminals [16]. - The number of clinical trial institutions for medical devices has increased, enhancing the regulatory environment and supporting industry growth [17][20]. Market Size and Growth - The AI medical device market is projected to grow significantly, driven by the increasing adoption of AI technologies in healthcare and the expansion of applications in various medical fields [30][33]. Policy Support - Government policies have been instrumental in promoting the development of the AI medical device industry, with various initiatives aimed at encouraging innovation and regulatory clarity [32][35]. Competitive Landscape - The competitive landscape of the AI medical device industry is structured into tiers, with leading companies such as Shukun Technology in the first tier, followed by companies like United Imaging and Infervision in the second tier [38][39].