SKOUT system

by Iterative Health  · Based in United States → — Powering research, accelerating outcomes
Gastroenterology
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Regulatory Status Disclosed

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

Polyp Detection During Colonoscopy
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. The system uses advanced computer vision technology to recognize suspicious tissue and provide real-time feedback. When a polyp is detected, a bounding box appears and tracks the polyp as it moves across the visual field. SKOUT has demonstrated effectiveness in detecting difficult-to-see and flat lesions.
Real-Time Endoscopy AI
SKOUT functions as a real-time computer-aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. It provides immediate visual assistance to gastroenterologists by processing endoscopic video in real time.
Adenoma Detection Rate Improvement
Clinical trials have shown that SKOUT significantly improves adenoma detection. In a randomized controlled trial, SKOUT demonstrated a 27% relative increase in the detection of adenomas per colonoscopy (APC). This translates to an average of one additional adenoma detected for every 4.5 patients examined. SKOUT has also shown a 44% relative increase in 5-9 mm polyp detection in the proximal colon and a 29% relative increase in 5-9 mm polyp detection overall. Studies indicate that SKOUT can increase the Adenoma Detection Rate (ADR) without significantly increasing the resection of healthy tissue.
GI Pathology Analysis
The SKOUT system makes no judgment on whether a potential polyp is adenomatous or neoplastic and cannot assist with the decision to resect tissue. Users should rely on their medical training for resection decisions. The system is not intended to provide a primary interpretation of medical diagnosis.
IBD Assessment Tools
Iterative Health is also involved in using AI and machine learning to optimize clinical trials for inflammatory bowel disease (IBD), including patient selection, clinical evaluation, and treatment pathways. Their technology processes de-identified endoscopic videos and electronic health records to provide objective, reproducible scoring of disease severity in ulcerative colitis.
Quality Metrics Tracking
SKOUT contributes to enhancing procedure quality with increased adenoma detection. Higher adenomas per colonoscopy (APC) rates, which SKOUT improves, have been shown to lead to improved patient outcomes and a decreased incidence of colorectal cancer within three years of examination.
Endoscopy System Compatibility
The SKOUT system has hardware components to support interfacing with an endoscope. It is indicated for white light colonoscopy only. The system is designed to integrate seamlessly into existing clinical workflows and does not impact total procedure or withdrawal time.
Physician Tip

SKOUT is an assistive tool and not a replacement for clinical decision-making. Gastroenterologists are responsible for reviewing suspected polyp areas and confirming the presence or absence of a polyp based on their medical judgment. The system does not make judgments on polyp histology, and users should rely on their medical training for resection decisions. Over-reliance on software notifications rather than clinical decisions may lead to false positives or false negatives. The bounding box feature automatically disappears when a medical tool enters the frame to avoid obstructing the physician's view during polyp removal. SKOUT can help maintain high-quality colonoscopy throughout the day, potentially reducing physician fatigue.

SKOUT is designed to preserve existing workflows and does not impact total procedure or withdrawal time. Iterative Health has partnered with Provation, a provider of clinical productivity and workflow automation solutions, for the commercial availability and distribution of SKOUT. Iterative Health also collaborates with Takeda to leverage AI-driven endoscopic assessments for IBD clinical trials.

Details

Category Gastroenterology AI
Pricing Unknown
DeploymentThe SKOUT system integrates into existing clinical workflows.
Data ExportUnknown
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Gastroenterology

Support & Reliability

Training ProvidedUnknown

What the Web Says

The SKOUT system by Iterative Health is an AI-powered computer-aided detection (CADe) tool designed to assist gastroenterologists in identifying colorectal polyps during colonoscopies. It provides real-time feedback by highlighting potential polyps with a bounding box. Clinical studies indicate that SKOUT significantly improves adenoma detection rates (ADR) and adenomas per colonoscopy (APC) without increasing procedure time or affecting workflow.

Overall: Positive

Strengths

  • Increases adenoma detection rate (ADR) and adenomas per colonoscopy (APC).
  • Does not significantly increase total procedure or withdrawal time.
  • Integrates seamlessly into existing clinical workflows.
  • Aids in detecting difficult-to-see and flat lesions, including sessile polyps.
  • Low rate of false positives, minimizing distraction for physicians.
  • Helps maintain high-quality colonoscopies throughout the day, potentially reducing physician fatigue.

Limitations

  • One Reddit post raises concerns about a potential quid pro quo offer from Iterative Scopes to facilities for using their product, including legal fee reimbursement.
  • No specific negative reviews from physicians, healthcare IT, tech reviewers, G2, or Capterra were found in the search results for the SKOUT system by Iterative Health.

Based on reviews from: nih.gov, aihealthindex.io, iterative.health, mpo-mag.com, uniospecialtycare.com, fiercehealthcare.com, businesswire.com, empr.com, biospace.com, reddit.com

Last updated: 2026-10-30

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Press & Coverage

medtechspectrum.com
AI-Enabled Medical Devices: 100 Most Recent FDA Clearances (2025)
Iterative Health's SKOUT system received FDA clearance on May 9, 2025, classified as a gastrointestinal-urology device with product code QNP.
2025-05
fda.gov
SKOUT system FDA 510(k) Premarket Notification
The FDA issued a 510(k) clearance for the SKOUT system (K251126) on May 9, 2025, indicating it as a Class II gastrointestinal lesion software detection system.
2025-05
fortunebusinessinsights.com
AI in Endoscopy Market
Iterative Health's SKOUT system, a polyp detection platform, received FDA clearance in May 2025, revolutionizing AI endoscopy outcomes.
2026-10
fiercebiotech.com
Iterative Scopes goes a step further with FDA clearance in AI colonoscopy
In September 2022, Iterative Health (formerly Iterative Scopes) secured FDA clearance for its SKOUT system, an AI-powered computer vision technology designed to detect suspicious polyps during colonoscopies in real-time.
2022-09
nih.gov
Improvement in adenoma detection using a novel artificial intelligence-aided polyp detection device: a retrospective analysis
A study published in February 2021 demonstrated that the SKOUT system significantly increased the adenoma detection rate (ADR) during colonoscopies, with an overall ADR increase from 40.6% to 54.2%.
2021-02
fiercehealthcare.com
Iterative Health and Gastro Health Partner to Bring AI-Enabled Gastroenterology Technology to Endoscopy Centers
In January 2023, Iterative Health partnered with Gastro Health to integrate its AI-enabled gastroenterology technology, including the SKOUT system, into Gastro Health's endoscopy centers to standardize GI care.
2023-01
thieme-connect.com
From Vision to Precision: The Rise of Artificial Intelligence in Gastrointestinal Endoscopy
The SKOUT system is highlighted as an FDA 510(k) cleared AI-based technology for real-time computer-aided detection (CADe) of polyps with high precision and recall in real-world settings.
2026-03
researchnester.com
AI in Medical Devices Market Outlook
The SKOUT system by Iterative Health is listed among AI-enabled medical devices that received FDA clearance, with a decision date of December 22, 2025.
2026-04

Videos

Product demos, reviews, and walkthroughs for SKOUT system.

View all on YouTube

Frequently Asked Questions

The SKOUT system is designed to integrate seamlessly into your existing colonoscopy workflow without increasing total procedure or withdrawal time. It works in real-time, providing AI-assisted polyp detection by highlighting suspicious tissues with a blue bounding box on the monitor. This box disappears automatically if a medical tool enters the frame, ensuring your view is not obstructed during polyp removal.
Clinical studies have shown that the SKOUT system significantly improves adenoma detection rates (ADR). It demonstrated a 27% relative increase in the detection of adenomas per colonoscopy, meaning approximately one additional adenoma is resected for every 4.5 patients examined. Specifically, it showed a 44% relative increase in 5-9 mm polyp detection in the proximal colon and a 29% relative increase in 5-9 mm polyp detection overall.
Yes, the SKOUT system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). It is indicated as a computer-aided detection tool to assist qualified and trained endoscopists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
SKOUT is one of several FDA-approved AI-assisted polyp detection systems, including GI Genius and EndoScreener. While comparative studies are limited, real-world data suggests that both SKOUT and GI Genius improve adenoma and polyp detection, with SKOUT showing slightly higher ADR and adenomas per colonoscopy (APC) in one study, though no statistically significant differences were observed, suggesting comparable efficacy.
The SKOUT system is an assistive tool and does not replace your clinical judgment or expertise. It is intended to help identify potential colorectal polyps, and you remain responsible for reviewing suspected areas, confirming the presence or absence of a polyp, and making all clinical decisions, including resection. SKOUT is indicated for white light colonoscopy only and does not provide primary interpretation of endoscopic procedures, medical diagnoses, or treatment recommendations.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed SKOUT system

Funded through the company that built this tool.

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