SKOUT system
Overview
The SKOUT system by Iterative Health is a real-time computer-aided detection (CADe) software device designed to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. It utilizes advanced computer vision technology to recognize suspicious tissue and provides real-time visual feedback, typically a bounding box, that highlights and tracks polyps on the endoscopic monitor. SKOUT aims to enhance procedure quality by increasing adenoma detection rates, demonstrating a 27% relative increase in the detection of adenomas per colonoscopy in clinical trials. The system is designed to integrate seamlessly into existing clinical workflows without impacting total procedure or withdrawal time. Importantly, SKOUT is intended to augment, not replace, physician judgment and is not for primary interpretation of endoscopic procedures, medical diagnosis, or treatment recommendations.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Use Cases
- Colorectal cancer screening for adult patients
- Colorectal cancer surveillance for adult patients
- Assisting gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations
- Improving adenoma detection rates during GI procedures
- Enhancing overall procedure quality in gastroenterology practices
What Physicians Need to Know
SKOUT is an assistive tool, not a replacement for a full patient evaluation or physician judgment. Gastroenterologists are responsible for reviewing SKOUT's suspected polyp areas and confirming the presence or absence of a polyp based on their medical judgment. The system does not make judgments on whether a potential polyp is adenomatous or neoplastic, and users should rely on their medical training for resection decisions. Over-reliance on the software notification without clinical judgment may lead to false positives or negatives. SKOUT can help maintain a high-quality colonoscopy throughout the day, potentially reducing physician fatigue.
Iterative Health has partnered with Provation, a leading software and SaaS provider of clinical productivity and workflow automation solutions, for the exclusive distribution of SKOUT to academic centers, health systems, and GI-focused practices. The system is designed to integrate seamlessly into existing clinical workflows.
Details
| Category | Gastroenterology AI |
| Pricing | Unknown — unknown |
| Deployment | The SKOUT system integrates into existing clinical workflows. |
| Data Export | Unknown |
| Training | Unknown |
| Compliance | |
| BAA Available | Unknown |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Cleared AI-estimated SKOUT system received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on September 22, 2022, for adults undergoing colorectal cancer screening or surveillance. It is a real-time computer-aided polyp detection device. The device assists qualified and trained endoscopists in identifying potential colorectal polyps during colonoscopy examinations. SKOUT was evaluated in the largest U.S.-based multicenter clinical study for a computer-aided polyp detection (CADe) device. The study showed a 27% relative increase in the detection of adenomas per colonoscopy (APC) with SKOUT. It also demonstrated a 44% relative increase in the detection of 5-9mm polyps in the proximal colon and a 29% relative increase in detecting these polyps overall. The system integrates seamlessly into existing clinical workflows and does not increase total procedure or withdrawal time. When a potential polyp is detected, a bounding box appears on the procedure monitor and tracks the polyp. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the physician's view. SKOUT is indicated for white light colonoscopy only. Iterative Health has also received additional FDA clearances for the SKOUT system, including K251126 on May 9, 2025, and K253664 on December 22, 2025. |
| Integrations | |
| EHR | Not specified |
| Specialties | Gastroenterology |
Social Proof
| Usage | Iterative Health's global site network spans over 100 sites across three continents. |
Support & Reliability
| Training Provided | Unknown |
What the Web Says
The SKOUT system by Iterative Health is an AI-assisted polyp detection device designed to enhance colorectal cancer screenings during colonoscopies. It uses computer vision to identify potential polyps in real-time, providing visual feedback to gastroenterologists. Clinical trials have shown that SKOUT significantly improves adenoma detection rates without increasing procedure time or the number of unnecessary biopsies.
Overall: PositiveStrengths
- Increased adenoma detection rate (ADR), with one study showing a 27% relative increase in adenomas per colonoscopy.
- Does not significantly increase total procedure time or withdrawal time.
- Aids in detecting difficult-to-see and flat lesions.
- Reduces variability in screenings based on provider factors, supporting consistently high-quality procedures.
- Intuitive user interface that seamlessly integrates with existing clinical workflows.
- FDA-cleared and clinically proven.
Limitations
- No specific cons were identified in the provided search results.
- No reviews from Reddit, G2, or Capterra were found.
- SKOUT is not intended to replace a full patient evaluation or physician judgment.
Based on reviews from: Iterative Health, Obvious Ventures, Fierce Biotech, Tracxn, AiThority, Business Wire, BioSpace, Healthcare Technology Report
Last updated: 2026-10-19
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