AI Medical Imaging Approved by China's NMPA: Cancer Screening Enters the 'Minute-Level' Era
China's NMPA approves the first AI cancer screening system MedSight Pro, covering five high-incidence cancers with a 3-minute scan time and over 97% accuracy.
Regulatory Clearance
China's National Medical Products Administration (NMPA) today granted Class III medical device registration to the AI early-detection suite MedSight Pro—the country's first multi-cancer AI screening system cleared for the market.
Co-developed by BGI and Tsinghua University, MedSight Pro screens for lung, liver, stomach, colorectal, and breast cancer.
Core Capabilities
Screening Workflow
After CT or MRI acquisition, MedSight Pro finishes full analysis in 3 minutes, outputting:
- Positive / negative call
- Suspected lesion location and size
- Malignancy score (0–100%)
- Follow-up recommendations
Accuracy
| Cancer type | Sensitivity | Specificity | Stage I detection rate |
|---|---|---|---|
| Lung | 97.3% | 94.1% | 91.2% |
| Liver | 96.8% | 95.5% | 88.7% |
| Stomach | 95.2% | 93.8% | 85.3% |
| Colorectal | 97.9% | 94.6% | 90.1% |
| Breast | 98.1% | 95.2% | 92.4% |
Versus Manual Reads
| Dimension | Manual radiology | MedSight Pro |
|---|---|---|
| Read time | 15–30 minutes | 3 minutes |
| Stage I pickup | 40–55% | 85–92% |
| Miss rate | 8–15% | <3% |
| Clinician load | High | Lower (confirm AI marks) |
Rollout
Pilot programs finished at Peking Union Medical College Hospital, Shanghai Ruijin, and Sun Yat-sen University Cancer Center. Next steps:
- Q3 2027: Expand to 50 tier-A hospitals
- Q4 2027: Add to provincial reimbursement lists in selected regions
- 2028: Broader coverage in major cities
Pricing
A single screening is expected to cost ¥800–1,200; with insurance, out-of-pocket could fall to ¥200–400.
Significance
The director of the Cancer Hospital, Chinese Academy of Medical Sciences, said:
"The bottleneck in cancer screening isn't imaging quality—it's coverage. We want cancers found at stage I, pushing curability above 90%."
Disclaimer
Content is AI-generated. Do not use it as a basis for real decisions. Do not cite it as factual reporting.