Since the beginning of this year, multiple AI medical device products have obtained the Class III Medical Device Registration Certificate issued by the National Medical Products Administration. The focus of industry applications is shifting from traditional auxiliary diagnosis to auxiliary treatment, and the pace of software and hardware integration iteration is significantly accelerating.
The industry has formed a consensus that the focus of enterprise operations must be on clinical scenario adaptation, product safety and effectiveness verification, and prioritize the registration and certification of three types of medical devices. Only products that have obtained complete compliance qualifications will gain advantages in the normalized clinical application within the hospital.
In terms of product form, the industry is moving from external AI software and single function independent devices to a new stage of integration of software and hardware, multi surgical compatibility, and closed-loop diagnosis and treatment. AI has been upgraded from auxiliary additional functions to the underlying control core for the overall operation of the machine.
The business model is also evolving - AI medical devices are gradually breaking away from a single software or hardware sales model, forming a sustainable and diversified revenue structure of one-time hardware payment plus consumables, system operation and maintenance, and version upgrades. At the same time, related products continue to penetrate into county-level hospitals and physical examination institutions, effectively addressing the shortage of grassroots medical technicians.