At the just-concluded 93rd CMEF (China International Medical Devices Expo), “AI” seemed to be everywhere. From imaging diagnostics to the operating table, from professional hospital equipment to health rings worn on ordinary people’s fingers, AI is driving a foundational transformation of the healthcare industry at a visible pace. Outside the exhibition halls, the pathway for China’s AI medical devices — from market access to commercial closed-loop formation — is also being progressively cleared.
1. Reading China’s AI Medical Device Development Direction Through CMEF’s Star Products
There are currently three important breakthrough directions in China’s AI medical devices: medical imaging AI (the most mature in real-world deployment, evolving from single-point assisted diagnosis toward full-process intelligent agents); surgical robot AI (from navigation to precision execution, redefining what it means for “AI to be the lead surgeon”); and home health management AI (wearable devices combined with intelligent monitoring, advancing devices from “in-hospital tools” to “out-of-hospital health managers”). This year’s CMEF brought together nearly 5,000 brand enterprises, with AI products blossoming everywhere. All three major directions featured star products that commanded attention.
Imaging AI — Measuring the “Chinese Brain” With a “Chinese Ruler”
The MR Intelligent Agent launched by Wandong Medical is the first domestically developed diagnostic product based on Chinese brain data. Drawing on MRI data from nearly 50,000 healthy individuals across the country, it has constructed an exclusive recognition model for the Chinese brain. China has more than 15 million Alzheimer’s disease patients, 80% of whom are diagnosed only when the disease has already reached the middle or late stage — partly because European and American brain structure standards have long been used as the reference. Wandong’s approach advances the early screening window by three to five years, with a diagnostic accuracy rate of 95%.
Surgical Robots — From “Single-Point Combat” to “All-Round Generalist”
United Imaging Group showcased its “Magic Cube Orthopedic Operating Room,” equipped with the industry’s first-of-its-kind LingLi Perception Orthopedic Robot. This orthopedic robot is compatible with two major indications — spinal and trauma — and features sub-millimeter positioning precision. Its proprietary mechanical visualization technology precisely visualizes the surgeon’s tactile sense and experience; through a high-sensitivity force sensing system at the end of the robotic arm, it can monitor in real time the interaction forces between the sleeve and soft tissue. Changmugu Medical has developed ROPA6, the world’s first “six-in-one” AI full-orthopedic surgical robot platform, which has received regulatory approval for market launch. A single system accommodates six major surgical procedures covering the hip, knee, spine, trauma, and more. Whereas a device previously could only address one body part, a single system can now handle the full range of orthopedic surgeries — whether this will redraw the subspecialty map of orthopedics is an open question that has captured industry attention.
Home AI — A Health Ring on Your Finger
Yuwell Medical launched the Health Ring R3 and the smart watch Yuwell Watch A1, integrating blood pressure, electrocardiogram, and blood oxygen monitoring into the fingertips. Cofoe Medical brought the Xinghe Generation 2 AI ventilator and the Zhi Lian atrial fibrillation blood pressure monitor. The family doctor of the future may truly be a ring worn on the finger, directly connected to the cloud to deliver health alerts and personalized health management plans.
2. Market Access: The Full Pathway From “Birth Certificate” to “Billing Certificate” Is Now Open
Regulatory Side: Innovation Approval Has Hit the Accelerator
Throughout 2025, the National Medical Products Administration (NMPA) approved 3,402 medical device products for market launch in total, of which 76 were innovative medical devices — a year-on-year increase of 17%, maintaining a high level for three consecutive years. More significantly, on April 2, 2026, the NMPA issued the Implementation Opinion on “Artificial Intelligence + Drug Supervision” (Guoyaojian Zong [2026] No. 6), which for the first time established at the top-level design level the strategic position of AI across the full lifecycle supervision of medical devices. The objective is to preliminarily build an AI-integrated innovation system by 2030 and to form a new landscape of intelligent governance by 2035. This means that the registration and approval of AI medical devices will not “decelerate” — on the contrary, as the regulatory system itself undergoes intelligent upgrading, it will enter the fast lane.
Healthcare Insurance Side: From “No Path to Billing” to “A Price to Follow”
For a long time previously, AI medical devices faced the awkward situation of “hospitals deploying one by one with no path to healthcare insurance billing.” From the end of 2025 to early 2026, the National Healthcare Security Administration (NHSA) moved in rapid succession.
For AI-assisted diagnosis: The Guideline for Establishing Pathology-Type Medical Service Price Items explicitly listed “artificial intelligence-assisted diagnosis” as an extended item for pathological diagnosis, incorporating it into the price structure. Taking the “clinical scale assessment fee” as an example, if the government-guided price is RMB 100 (≈ USD 13.89), an additional RMB 80 (≈ USD 11.11) may be charged when AI-assisted assessment is used, bringing the total to RMB 180 (≈ USD 25).
For surgical robots: In January 2026, the NHSA issued the Guideline for Establishing Surgery and Treatment Auxiliary Operation-Type Medical Service Price Items, adopting a three-tier pricing structure of “navigation, participatory execution, and precision execution,” and establishing a remote surgical auxiliary operation fee.
Local governments moved quickly to follow suit. In April 2026, the Hunan Provincial Medical Insurance Bureau became the first to implement billing standards for surgical robots — navigation-type procedures may charge an additional 50% surcharge on top of the primary surgery fee (maximum RMB 3,600, ≈ USD 500); participatory execution-type at an additional 150% (maximum RMB 12,000, ≈ USD 1,667); precision execution-type at an additional 300% (maximum RMB 26,000, ≈ USD 3,611); and remote surgery-type at an additional 500% (maximum RMB 37,000, ≈ USD 5,139). Industry assessment: this is a milestone marking “policy moving from ambiguity to clarity.”
3. The Market Is Enthusiastically Embracing the Intelligentization of Medical Devices
Overall Scale: The Leap From Hundreds of Millions to Tens of Billions
Data from the China Medical Equipment Association shows that China’s medical equipment market reached RMB 1.44 trillion (≈ USD 200 billion) in 2025, up approximately 7% year-on-year. According to research by Rong Zhong Consulting, AI standalone software (SaMD) recorded a compound annual growth rate of 260% from 2020 to 2024, with a market size of approximately RMB 4.8 billion (≈ USD 667 million) in 2025; AI embedded software (SiMD) had a compound annual growth rate of 43%, with a market size of RMB 49.5 billion (≈ USD 6.88 billion) in 2025. By 2030, the penetration rate of SiMD in assisted diagnostic devices is expected to exceed 90%.
Imaging AI: A RMB 28.5 Billion Market (≈ USD 3.96 Billion), With Reading Time Shortened by 53%
The AI medical imaging market for diagnostic applications grew from less than RMB 1 billion (≈ USD 139 million) in 2020 to RMB 28.5 billion (≈ USD 3.96 billion) in 2025, with a compound annual growth rate of 122%. AI reading time is 53% shorter than manual reading, and detection rates have improved by 17.6%. United Imaging Medical’s “one scan, multiple checks” AI intelligent agent can precisely identify 73 common chest conditions and 43 common brain conditions, and has already been deployed at nearly 30 hospitals across the country. Wandong’s “Lingxi” intelligent agent serves approximately 200 healthcare institutions and processes approximately 1,500 chest X-ray reports daily.
Surgical Robots: A RMB 10.88 Billion Market (≈ USD 1.51 Billion), With Domestic Market Share Surging
China’s surgical robot market is estimated at RMB 10.88 billion (≈ USD 1.51 billion) in 2025, with the potential to reach RMB 28.72 billion (≈ USD 3.99 billion) by 2030. In 2025, a total of 52 surgical robots received domestic approval, of which 23 were orthopedic surgical robots, accounting for more than 44% of the total. Tianzhihang holds a domestic installed market share of more than 40% in orthopedic surgical robots, with cumulative surgical volume exceeding 150,000 procedures; Micro-port Robotics’ laparoscopic robot has accumulated global orders exceeding 160 units. The two domestic medical device giants, United Imaging Medical and Mindray Medical, have also entered or are on the verge of entering the surgical robot battlefield.
Home AI: Starting With a RMB 1,299 Ring (≈ USD 180)
Yuwell’s Health Ring R3 is priced at RMB 1,299 (≈ USD 180) and has already launched on e-commerce platforms — the consumer-side commercial closed loop is accelerating into formation.
AI medical devices are currently at a critical window in which they are transitioning from technology validation to large-scale commercialization. On the policy side, the regulatory approval channel is clear and the healthcare insurance billing pathway is defined. On the industry side, leading enterprises have already formed an integrated model of “hardware + software + data + services.” It is foreseeable that over the next few years, AI medical devices will move from “single-point breakthroughs” toward “full-process penetration,” and from “in-hospital exclusive use” to “out-of-hospital popularization.” With 2026 marking the inaugural year of implementation for the healthcare insurance billing establishment guidelines, the industry is poised to formally enter a period of rapid development.
[Disclaimer]: The above content reflects analysis of publicly available information, expert insights, and BCC research. It does not constitute investment advice. BCC is not responsible for any losses resulting from reliance on the views expressed herein. Investors should exercise caution.