China Approves Wave of AI Medical Devices, Boosting MedTech

China’s National Medical Products Administration (NMPA) has approved a wave of artificial intelligence-powered medical devices in the first half of 2026, spanning cervical pathology, gastric lesion detection, orthopedic surgery robotics, chromosome karyotyping, and nuclear medicine. The approvals mark a critical acceleration in the commercialization of AI within China’s healthcare sector, according to a report from Xinhua News.

As of mid-2026, the NMPA has approved a cumulative total of 127 AI medical software products, with 126 classified as Class III — the highest-risk and most rigorously regulated category of medical devices. The approval trend has grown steadily from just 6 products in 2021 to a record 36 in 2025, with 13 already approved in the first half of 2026, according to data compiled by China MedGlobal.

Key Products Approved in 2026

Among the notable approvals this year, Yice Technology received a Class III certificate for its cervical cell digital pathology image-assisted diagnosis software, which achieves a 100% improvement in screening efficiency and a 60% reduction in missed diagnosis rates. The product has been deployed in hundreds of domestic medical institutions and has expanded into overseas markets.

In February, Chujingling obtained approval for its gastric lesion electronic endoscope image-assisted triage software, capable of identifying high-grade intraepithelial neoplasia and above lesions. March saw Changmugu Medical’s ROPA6 AI-powered full orthopedic surgery robot receive its Class III certificate, alongside Jingfeng Medical’s three-in-one integrated surgical robot platform.

Deshi Biotechnology achieved a milestone on May 20 when its AI AutoVision chromosome karyotype-assisted diagnosis software became the first product globally based on a medical imaging foundation model to receive Class III certification. A 1,734-patient multicenter clinical trial demonstrated 100% sensitivity and specificity for numerical abnormality detection, as reported by Sina Finance.

United Imaging Intelligence further strengthened its leading position by obtaining China’s first nuclear medicine AI Class III certificate for its thoracic nuclear medicine image-assisted triage software, bringing its total to 20 Class III certificates — the most of any company.

From Diagnosis to Treatment: A Critical Transition

Industry analysts note that the latest wave of approvals signals a fundamental shift from AI-assisted diagnosis to AI-assisted treatment. Multiple surgical navigation and robotic surgery products have received market access, marking what experts describe as a critical advancement for domestic AI medical technology.

“The industry has formed a unified consensus: enterprises must focus on clinical scenario adaptation, product safety and effectiveness validation, and standardized use of medical data,” said Wang Xiaomei, Founder and CEO of Yice Technology, in an interview with Xinhua. “Only products with complete compliance qualifications will gain advantages in routine clinical applications within hospitals.”

Market Landscape: Red Oceans and Blue Oceans

Domestic companies dominate the market with 94.5% of approved products, while imported products account for just 5.5%. Shanghai United Imaging Intelligence and Shukun Technology lead the market with 17 certificates each, followed by DeepWise and Infervision with 12 each, and Siemens Healthineers with 8 as the largest foreign holder.

The competitive landscape varies significantly by clinical modality. Lung nodule and pulmonary imaging (32 certificates) and cardiovascular imaging (22 certificates) have become highly competitive “red oceans.” In contrast, pathology and cytology (5 certificates), endoscopy and digestive imaging (6 certificates), and ultrasound (3 certificates) remain relatively open “blue ocean” opportunities with significant growth potential.

Product Integration and Commercialization

AI medical devices are evolving from standalone software applications toward integrated hardware-software platforms. Companies are shifting from one-time product sales to recurring revenue models based on consumables, system maintenance, and version upgrades.

Mao Xinsheng, Founder and Chairman of Shukun Technology, noted that “medical AI is upgrading from a professional auxiliary tool to a new quality productive force in the medical field, becoming a core support for next-generation diagnosis and treatment.” However, he cautioned that “the industry still needs to further establish clear compliance approval pathways to ensure new technologies and products have legal market authorization.”

What’s Next

Looking ahead, AI medical devices are expected to expand further into county-level and grassroots medical institutions, helping to bridge the diagnostic capability gap between urban and rural areas. Wang Xiaomei predicted that future product architecture will shift toward lightweight, edge-deployable solutions that reduce hardware costs for smaller hospitals.

The NMPA continues to develop regulatory frameworks for medical large language models and AI-powered devices, while the Ministry of Industry and Information Technology has issued an implementation plan for the digital and intelligent transformation of the pharmaceutical industry. China’s core AI medical imaging market is projected to grow from approximately 24 billion RMB in 2024 to 401 billion RMB by 2030, according to Frost & Sullivan.