What happened
Ankon Technologies of Wuhan, China, makes NaviCam ProScan, software based on convolutional neural networks that marks suspected lesions in capsule endoscopy videos of the small bowel. The prospective ARTIC study enrolled patients with suspected bleeding in the small bowel at seven European centers in 2021 and 2022. Each video was read first without AI at the enrolling center, then by readers at another center with AI assistance. An expert board set the reference. FDA reviewers report that diagnostic yield for lesions with high or moderate bleeding potential was 73.7% with AI and 62.4% without, among 133 patients. Mean reading time fell from 33 minutes and 42 seconds to 3 minutes and 50 seconds. All lesions missed in standard reading were found with AI. FDA granted the De Novo request on 12 December 2023. FDA notes that the device was not tested without a clinician, and its standalone specificity per patient was 37% in internal testing.
Sources
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Regulatory document, by authors with no tie to the system.
U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for NaviCam ProScan (DEN230027): decision summary. Granted 2023-12-12.
At per-patient analysis, diagnostic yields for P1+P2 lesions were 62.4% (95% CI: 53.6% - 70.7%) and 73.7% (95% CI: 65.3% - 80.9%), for standard readings and AI+Physician readings, respectively (p=0.015).
Details
AI system
- Workflow
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The software marked suspected lesions with bounding boxes and could show only the flagged images. Readers with over 500 capsule readings each reviewed the AI output and made their own diagnoses.
Follow-up
- Conditions for replication
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Videos come from the NaviCam Small Bowel Capsule Endoscopy System. The clinician reviews the entire video as clinically appropriate.
Entry details
- Sector
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Healthcare.
- Purpose
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Ankon Technologies built NaviCam ProScan to help clinicians read capsule endoscopy videos of the small bowel faster by marking images with suspected lesions.
Not yet checked: model, release, 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). NaviCam ProScan cut capsule reading time and found more lesions (AIBD-0775). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0775.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)