Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 5, 2026
Back to directorySKOUT medical AI product profile
Iterative Health real-time polyp detection system that gives gastroenterologists computer-aided location information during colonoscopy.
Medical imaging and radiology
Best fit
GI programs comparing FDA-cleared computer-aided polyp detection tools for screening and surveillance colonoscopy with quality-measure monitoring.
- Primary use case
- Real-time AI-assisted colorectal polyp location support during adult screening or surveillance colonoscopy
- Audience
- Gastroenterology groups, ambulatory surgery centers, colorectal cancer screening programs, and endoscopy quality leaders
- Risk level
- High
- Pricing signal
- Enterprise and ASC pricing; verify current hardware, software, distribution, implementation, support, and service terms.
- Official sources
- 4 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating SKOUT as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Confirm the SKOUT 510(k), software version, labeling, intended adult population, white-light limitation, component compatibility, and any region-specific availability before clinical use. |
|---|---|
| Privacy | Review endoscopy-video flow, identifiers, support logs, retained quality metrics, processor roles, access controls, deletion, audit logging, and business-associate terms before room integration. |
| Evidence | Evaluate evidence for adenoma and polyp detection, sessile lesions, procedure time, false markers, missed lesions, resection mix, and whether results generalize to local endoscopists and case mix. |
| Workflow | Best governed as an assistive detection overlay with training, over-reliance safeguards, documentation expectations, downtime plans, and ongoing monitoring of colonoscopy quality metrics. |
Where SKOUT fits
Iterative Health describes SKOUT as real-time AI for polyp detection; its indications page states that SKOUT is a computer-aided detection tool for adult screening or surveillance colonoscopy, is limited to white-light colonoscopy, and does not replace medical judgment or make resection decisions. FDA 510(k) materials list SKOUT as a gastrointestinal lesion software detection system.
Not for: Primary interpretation, medical diagnosis, treatment recommendations, lesion characterization, resection decisions, unsupported patient groups, or use outside white-light colonoscopy.
What to verify before using SKOUT
- FDA 510(k) record, current labeling, intended adult screening or surveillance population, white-light requirement, and compatible SKOUT system components.
- How suspected-polyp notifications appear during the procedure and how endoscopists accept, reject, document, or ignore them.
- Whether the deployment captures, transmits, stores, or logs endoscopy video, patient identifiers, room metadata, support diagnostics, and quality metrics.
- Local effect on adenoma detection, clinically significant lesions, false positives, false negatives, procedure time, clinician reliance, and resection patterns.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- iterative.health / products / skout
- iterative.health / indications-warnings-and-risks
- iterative.health / latest-news / blog
- www.accessdata.fda.gov / cdrh_docs / pdf23
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