What happened
Changsha Huiwei Intelligent Medical Technology built HW-ES, deep learning software that shows suspected polyps in real time on a separate video screen during adult colonoscopy. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a prospective, stratified randomized, single-blind trial with sequential examinations at three sites. It enrolled 354 patients, split equally between the two groups. At lesion level, the polyp miss rate was 12.41% with the software and 50.80% without, a difference of -38.39% (95% CI -42.87% to -33.58%). The adenoma miss rate was 17.95% against 28.93%. The adenoma detection rate at the first examination showed no statistically significant difference between the groups. On 16 December 2024, CMDE concluded that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. The report does not define a missed polyp or say whether the software changed any patient's treatment.
Sources
-
Regulatory document, by authors with no tie to the system.
主要评价指标:息肉漏诊率,FAS 集病灶水平,试验组为 12.41%,对照组为 50.80%,组间差值为-38.39%
根据申请人提供的申报资料,经综合评价,在目前认知水平上,认为该产品的上市为适用人群带来的受益大于风险。
Details
AI system
- Reported configuration
-
Release V1
- Workflow
-
A dual-stream deep convolutional neural network checked each video frame, and a sliding-window algorithm removed likely false alarms. The software showed suspected polyp areas in real time on a separate video output from the endoscope's image processor.
Follow-up
- Conditions for replication
-
Patients are adults aged 18 to 85 with adequate bowel preparation. The specified endoscope models are used in white-light mode. Endoscopists judge each mark and do not base a clinical decision on the software alone.
Entry details
- Sector
-
Healthcare.
- Purpose
-
Changsha Huiwei Intelligent Medical Technology built HW-ES to show licensed endoscopists the areas of suspected polyps in real time during adult colonoscopy.
29 more questions not yet checked
model, provider, role, configuration, inputs and outputs, autonomy, human oversight, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.
Cite this record
Peter H. Vartanian. (2026). HW-ES helped endoscopists miss fewer colon polyps in a trial (AIBD-1060). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1060.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)