SKOUT
Iterative Health
Computer-aided detection overlay for live colonoscopy, flagging suspected colorectal polyps as the endoscopist withdraws.
At A Glance
- Manufacturer
- Iterative Health
- Medical specialty
- Gastroenterology
- Clearance route
- 510(k)
- Year authorized
- 2022
- Modality
- Colonoscopy video
- Role in workflow
- Real-time detection
SKOUT following GI Genius through 510(k) is the same predicate story as EyeArt following IDx-DR. The De Novo device establishes the category and the special controls, and subsequent devices in that category take the shorter route.
Where It Is Used
- Adenoma detection support
- Screening colonoscopy quality improvement
Limitations Worth Knowing
Detection overlays raise sensitivity and also raise false flags, each of which costs procedure time. The tool cannot compensate for inadequate bowel preparation or rushed withdrawal, which remain the dominant determinants of what gets found.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.