眼科手术机器人领域正迎来注册认证的关键节点。迪视医疗、瞳沐医疗、微眸医疗三家国内企业已分别于2025年3月和2026年6月、7月进入创新医疗器械特别审查通道，争夺眼科手术机器人的首张注册证[1]。这一突破旨在解决眼底手术领域长期存在的医疗资源紧张问题——国内开展高难度眼底手术的成熟医师不足50人，但眼底病变患者数千万[1]。
眼科手术机器人的核心优势在于精度突破。眼底手术需要10微米级操作精度，但人手生理抖动幅度达100微米[1]。迪视医疗的研究数据显示，其机器人辅助组的手术漂移量为41.07微米，而手动组高达299.66微米[1]。瞳沐医疗的眼底注射机器人执行精度更是达到2微米[1]。微眸医疗则于2025年完成了跨越4200公里的远程视网膜下注射手术，整个手术耗时不到7分钟[1]。视网膜下注射已被视为首个具有临床可行性的落地场景[1]。
国际对标方面，海外仅一家企业的眼科手术机器人产品取得CE认证，其余仍处于临床试验阶段[1]。与此同时，国内显微外科手术机器人的发展也在加速，昂泰微精、深度医疗的相关产品计划于2026年上半年进入创新医疗器械特别审查通道[1]。
Three Chinese companies developing ophthalmic surgical robots are simultaneously pursuing their first regulatory certifications, with timeline milestones set for 2025 and 2026.[1] Dishi Medical, Tongmu Medical, and Weimu Medical have entered the expedited review pathway for innovative medical devices, with approvals expected in March 2025, June 2026, and July 2026 respectively.[1]
These robotic systems address a critical precision gap in eye surgery. While retinal procedures require 10-micrometer-level operational accuracy, the human hand exhibits involuntary tremors of approximately 100 micrometers.[1] Clinical data demonstrates the performance differential: in Dishi Medical's research, robot-assisted procedures achieved a drift measurement of 41.07 micrometers compared to 299.66 micrometers for manual operations.[1] Tongmu Medical's retinal injection robot achieves an execution precision of 2 micrometers.[1] The potential clinical impact is substantial given the stark shortage of expertise—fewer than 50 qualified physicians in China perform complex retinal surgeries, while tens of millions of patients suffer from retinal diseases.[1]
Subretinal injection has emerged as the leading application pathway for commercialization.[1] Weimu Medical demonstrated this capability in 2025 by completing a remote subretinal injection surgery spanning 4,200 kilometers in under seven minutes.[1] Internationally, the competitive landscape remains nascent, with only one company having obtained CE certification; other developers remain in clinical trial phases.[1] Beyond ophthalmology, the broader microsurgical robotics sector is expanding—Ongtai Microprecision and Deepdepth Medical's microsurgical robots entered the expedited review pathway in the first half of 2026.[1]
