Comparative analysis of artificial intelligence-enabled medical devices in the state registries of the USA, China, and Russia

Objective: To compare the state of artificial intelligence-enabled medical devices (AIeMDs) of the USA, China and Russia in terms of scale, dynamics of registrations, structure of the main areas of medical application (medical specialty) and the developing country, to characterize AIeMDs registered in the Russian Federation.

Material and methods. The registries of the United States Food and Drug Administration (FDA) (1,524 AIeMDs as of March 2026), Federal Service for Supervision of Health Care and Social Development (Roszdravnadzor, RZN) (57 AIeMDs as of April 2026) and China National Administration National Medical Products Administration (NMPA) (for NMPA data from peer-reviewed publications were used that identified 154 MI with AI as of June 2025), taking into account the year of issue of the permit or registration certificate, the field of medical application (medical specialty), the tasks and capabilities of AIeMDs, the country- the developer.

Results. In terms of the number of AIeMDs registrations, the FDA registry surpasses the NMPA by approximately 10 times, and the RZN registry by 27 times (1,524, 154 and 57 AI‑based medical devices, respectively). The number of AIeMDs registrations in all registries shows steady growth: in 2025, 333 AIeMDs were registered in the USA, 45 in China, and 13 in Russia. The registries are dominated by AIeMDs for medical image analysis. In the FDA registry, radiation diagnostics account for 76.4% of MI, in the NMPA registry – 68.8%, in the RH registry – 59.6%, and the total share of AIeMDs for image analysis is 77.6%, 83.8% and 75.4%, respectively. Since 2022, the FDA registry has been gradually diversifying and reducing the share of medical image analysis in favor of programs for cardiology and neurology. 91.2% of AIeMDs registrations in the RZN register are represented by domestic developers, whereas in the FDA register, the share of foreign manufacturers reaches 57.7%. The structure of manufacturers also differs: in the USA, multinational corporations dominate; in China, specialized national‑scale AI companies; and in Russia, independent domestic software developers. Geographical concentration is characteristic of both China and Russia: 77.9% of Chinese AIeMDs are manufactured in four cities, and the Russian register is predominantly formed by developer companies from Moscow.

Conclusion. A direct comparison of the absolute values of registries is not informative due to differences in scale, timing of accounting and classification principles. A correct comparison is possible at the level of a generalized structure and reveals a general pattern: the introduction of AI into clinical medicine is leading to the analysis of medical images, particularly in radiology.

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