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Industry Insights · Device Segments & Clinical

AI medical devices 2025: a RMB52.5bn market and the 'screen-diagnose-treat-manage' upgrade

AI is reshaping device workflows; but beyond imaging and algorithms, hardware and materials remain the foundation for deployment.

2026-06-19BIO Industry Insights

Bar chart of AI medical-device market size (2023/2025E/2028E)
Fast growth: ~RMB4.4bn in 2023, projected ~RMB52.5bn by 2028. Figures are research forecasts, orders of magnitude.
In short: AI medical devices use AI on 'medical-device data' for medical purposes (regulated by NMPA's 2022 review principles). The market grew from RMB125m to RMB4.37bn over 2019–2023 (143.33% CAGR) and is projected to rise from RMB6.499bn to RMB52.485bn over 2024–2028 (68.58% CAGR); by end-2023, 81 AI devices held Class III certificates. Ten representative firms include Shukun, Deepwise, Infervision, United Imaging, Pulse Medical, Neusoft Medical, Airdoc, Keya Medical, Xingmai and Arteryflow. Trends: multimodal and generative AI upgrading care, full-lifecycle regulation speeding compliance, expansion into primary-care and consumer markets, and industry-academia integration with internationalization.

Ten brands and the evaluation lens

Leaders are judged on three axes: technical innovation and R&D; clinical value and compliance (NMPA/FDA/CE); and market influence and commercialization. Products cluster in imaging-aided diagnosis (fundus, coronary, stroke), a clear 'software + imaging' character.

An overlooked fact: hardware materials dominate cost

On the supply side of AI imaging equipment, raw materials are ~85% of cost (e.g., magnets RMB700k–800k each, tubes RMB110k–130k); core components were long bottlenecked, and mid/low-end imaging components are now largely localized. The point: however smart the algorithm, it still rides on reliable hardware and materials.

The BIO angle

AI devices are mostly imaging/software, seemingly far from silicone; yet 'materials ~85% of cost' and 'core-component localization' show device competition ultimately returns to the hardware-and-materials base. BIO's high-performance medical-silicone supply and selection is that base, on the materials side.

FAQ

How big is the AI medical-device market?

From RMB125m to RMB4.37bn over 2019–2023, projected ~RMB52.485bn by 2028; 81 devices held Class III certificates by end-2023.

Who are the leading Chinese firms?

Often-listed leaders include Shukun, Deepwise, Infervision, United Imaging, Pulse Medical, Neusoft Medical, Airdoc, Keya Medical, Xingmai and Arteryflow.

Why do materials remain the base?

Raw materials are ~85% of AI imaging-device cost and core components were bottlenecked; beyond algorithms, reliable hardware and materials decide whether a product truly deploys.

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Note: an original analysis compiled from public industry information; figures and conclusions per official/original sources. Not investment advice.

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