Medical imaging and radiology
SKOUT
Iterative Health real-time polyp detection system that gives gastroenterologists computer-aided location information during colonoscopy.
Last updated: June 14, 2026
Back to directoryGI Genius medical AI product profile
Medtronic endoscopy AI module that overlays real-time markers to help endoscopists detect colonic mucosal lesions during colonoscopy.
Medical imaging and radiology
Best fit
Endoscopy programs evaluating FDA-authorized AI-assisted colonoscopy for colorectal polyp detection while preserving physician interpretation and pathology workflows.
- Primary use case
- Real-time computer-aided polyp detection support during standard white-light colonoscopy
- Audience
- Gastroenterology groups, endoscopy centers, hospitals, colorectal cancer screening programs, and clinical AI governance teams
- Risk level
- High
- Pricing signal
- Enterprise device and service pricing; verify current module, software version, equipment compatibility, maintenance, and regional availability.
- Official sources
- 4 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA De Novo authorized prescription computer-assisted detection device for colonoscopy. |
|---|---|
| Review route | De Novo DEN200055. |
| Intended use | Adjunctive real-time detection support for colonic mucosal lesions during standard white-light endoscopy; it does not diagnose or replace histopathology or physician judgment. |
| Verification note | Confirm software version, compatible endoscopy equipment, labeling, prescription-use restrictions, training, and how alerts are documented or ignored. |
| Source | www.accessdata.fda.gov / cdrh_docs / reviews |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating GI Genius as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify the exact GI Genius module, labeling, De Novo record, software version, intended use, prescription restriction, and country-specific status before using it in screening or surveillance workflows. |
|---|---|
| Privacy | Map whether the deployment processes, stores, transmits, or logs endoscopy video, patient identifiers, room metadata, support diagnostics, and service records under the provider's privacy and security agreements. |
| Evidence | Review clinical evidence for the target screening population, adenoma detection rate, missed lesions, false-positive markers, operator reliance, withdrawal time, and impact on pathology-confirmed outcomes. |
| Workflow | Best governed as real-time endoscopist decision support with explicit rules for training, visual-marker response, biopsy decisions, downtime, documentation, and periodic performance review. |
Where GI Genius fits
Medtronic describes GI Genius as an AI-powered, first-to-market computer-aided polyp detection system for colonoscopy; the product labeling says it is adjunctive, does not diagnose, does not replace clinical decision-making or histopathology, and is limited to standard white-light endoscopy. FDA De Novo materials classify GI Genius as a prescription computer-assisted detection device.
Not for: Autonomous diagnosis, lesion characterization that replaces biopsy, unsupported endoscopy equipment, non-white-light workflows, or use outside the cleared indication.
What to verify before using GI Genius
- FDA De Novo authorization, current labeling, software version, contraindications, prescription-use requirements, and geography-specific availability.
- Compatibility with the endoscopy processor, display chain, room setup, electromagnetic safety requirements, and validated equipment list.
- How visual markers are reviewed, ignored, documented, escalated, and reconciled with endoscopist assessment and histopathology sampling.
- Local effect on adenoma detection, missed lesions, false positives, withdrawal time, clinician reliance, training, and post-deployment monitoring.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.medtronic.com / en-us / healthcare-professionals
- news.medtronic.com / 2021-04-12-U-S-FDA-Grants-De-Novo-Clearance-for-First-and-Only-Artificial-Intelligence-System-for-Colonoscopy-Medtronic-Launches-GI-Genius-TM-Intelligent-Endoscopy-Module
- www.accessdata.fda.gov / cdrh_docs / reviews
- www.medtronic.com / content / dam
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