SKOUT system

by Iterative Health  · Based in United States → — Empowering exceptional GI care through relentless innovation in technology and services.
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 specifically designed to detect potential colorectal polyps in real-time during white light colonoscopy examinations. It provides a visual aid, typically a bounding box, around suspected polyps on the endoscopic monitor. It is particularly effective at aiding in the detection of flat and difficult-to-see polyps.
Real-Time Endoscopy AI
SKOUT operates as a real-time artificial intelligence tool, utilizing advanced computer vision technology to analyze endoscopic video feeds during colonoscopy procedures. It processes the video in real-time to identify and highlight potential polyps.
Adenoma Detection Rate Improvement
Clinical studies have demonstrated that SKOUT significantly improves adenoma detection rates (ADR). It showed a 27% relative increase in the detection of adenomas per colonoscopy (APC) in a randomized controlled trial. Specifically, it achieved a 44% relative increase in 5-9mm polyp detection in the proximal colon and a 29% relative increase in 5-9mm polyp detection overall.
GI Pathology Analysis
The SKOUT system is intended solely as an assistive tool for polyp detection and does not perform GI pathology analysis. It does not make judgments on whether a potential polyp is adenomatous or neoplastic, nor does it assist with resection decisions; these remain the responsibility of the gastroenterologist.
IBD Assessment Tools
While Iterative Health, the developer of SKOUT, is involved in optimizing clinical trials for Inflammatory Bowel Disease (IBD) and utilizing AI for identifying and grading IBD features, the SKOUT system itself is specifically indicated for colorectal polyp detection during colonoscopy and is not presented as an IBD assessment tool.
Procedure Documentation
SKOUT integrates seamlessly into existing clinical workflows without impacting total procedure or withdrawal time. While Iterative Health partners with Provation, a leader in GI documentation, SKOUT's primary function is detection, not direct procedure documentation.
Quality Metrics Tracking
SKOUT enhances procedure quality by increasing adenoma detection, contributing to improved quality metrics. It helps maintain a consistently high-quality colonoscopy throughout the day, potentially reducing variability in detection rates.
Endoscopy System Compatibility
The SKOUT system is designed for seamless integration into existing clinical workflows and processes high-definition endoscopic video in real-time. It features smart detection of endoscopic tools, pausing polyp detection when tools enter the visual field to avoid obstruction during procedures like biopsy or resection. It also supports most common forms of color blindness.
Physician Tip

Leverage SKOUT as an invaluable 'second set of eyes' to augment your perception during colonoscopies, especially for subtle or challenging polyps like flat lesions and those in the proximal colon. Remember that SKOUT is an assistive tool; always exercise your medical judgment to confirm polyp presence and make all clinical decisions regarding resection and patient management. Its real-time feedback can help maintain consistent procedure quality throughout the day, potentially reducing the impact of fatigue on detection rates. Integrate it smoothly into your workflow, as it's designed not to increase procedure time.

SKOUT is engineered for seamless integration into existing clinical workflows without increasing total procedure or withdrawal time. Iterative Health has partnered with Provation, a leading provider of clinical productivity and workflow automation solutions, which acts as an exclusive distributor to broaden SKOUT's reach within gastroenterology practices.

Details

Category Gastroenterology AI
Pricing Unknown
DeploymentSoftware device that integrates with existing colonoscopy systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

SKOUT received FDA 510(k) clearance (K253664) in September 2022. It is indicated as a computer-aided detection tool to assist qualified and trained endoscopists in identifying potential colorectal polyps during colonoscopy examinations.
Integrations
EHR Not specified
Specialties Gastroenterology

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Press & Coverage

Fierce Biotech
Iterative Health, Gastro Health partner over AI-enabled GI care and precision medicine R&D
Iterative Health and Gastro Health have partnered to bring AI-enabled gastroenterology technology, including the SKOUT system, to endoscopy centers, aiming to standardize GI care and expand clinical research capabilities. The SKOUT system, which received FDA clearance in September 2022, works in real-time to recognize potentially cancerous tissue and has shown a 27% increase in adenoma detection in clinical trials.
2023-01
Endoscopy International Open
From Vision to Precision: The Rise of Artificial Intelligence in Gastrointestinal Endoscopy
This narrative review discusses the significant role of AI in GI endoscopy, highlighting the SKOUT system as an FDA-cleared technology for real-time polyp detection. The article emphasizes AI's contributions to identifying and classifying polyps, ensuring quality adherence, and aiding in therapeutic procedures.
2026-05
Verified Market Research
AI in Endoscopy Market Size, Share | Growth Report [2026-2034]
The report on the AI in Endoscopy Market highlights Iterative Health as a significant firm prioritizing product validation and regulatory approvals for its SKOUT system. It notes the U.S. FDA's clearance letter for Iterative Health's SKOUT system in May 2025, classifying it as a gastrointestinal lesion software detection system.
2026-06
MarketWatch
AI Polyp Detection Device Market 2026 forecast to 2032
This market report identifies Iterative Scopes (Iterative Health) as a disruptor in the AI Polyp Detection Device market due to its FDA-cleared SKOUT system, which is multi-OEM compatible. The report emphasizes the increasing adoption of AI-driven medical technologies in North America, driven by a well-established healthcare infrastructure and a supportive regulatory environment.
2026-04
Endoscopy International Open
Improvement in adenoma detection using a novel artificial intelligence-aided polyp detection device
This study details the effectiveness of the SKOUT system, an AI-aided device using a deep neural network to identify potential polyps in real-time during colonoscopies. The research highlights SKOUT's ability to detect a significant number of adenomas, including flat sessile serrated lesions, with 97% of detected adenomas being less than 10 mm.
2021-02
Iterative Health (iterative.health)
SKOUT AI-Assisted Polyp Detection
The SKOUT system is a software device designed to detect potential colorectal polyps in real-time during colonoscopy examinations, acting as a computer-aided detection tool. It provides visual aids to gastroenterologists for identifying polyps and has demonstrated an improvement in adenoma detection rates.
unknown
accessdata.fda.gov
U.S. Food & Drug Administration 510(k) Clearance Letter K253664
This FDA clearance letter for the SKOUT system (K253664) confirms its classification as a Class II gastrointestinal lesion software detection system. It details the intended use of SKOUT as a software-based computer-aided detection (CADe) system to assist gastroenterologists in identifying potential colorectal polyps during colonoscopy procedures.
2025-12
accessdata.fda.gov
U.S. Food & Drug Administration 510(k) Clearance Letter K240781
This FDA 510(k) clearance letter (K240781) for the SKOUT system reiterates its intended use as a computer-aided detection tool for identifying colorectal polyps during colonoscopy examinations. It specifies that the system is meant to assist, not replace, the gastroenterologist's medical judgment.
2024-07

Videos

Product demos, reviews, and walkthroughs for SKOUT system.

View all on YouTube

Frequently Asked Questions

The SKOUT system is a real-time artificial intelligence (AI)-aided polyp detection device designed to assist gastroenterologists during colonoscopies. It uses advanced computer vision technology to identify suspicious tissue, highlighting potential colorectal polyps on the procedure monitor with a bounding box. This augmentation aims to increase the detection rate of adenomas, which can improve patient outcomes by identifying precancerous lesions earlier.
Yes, the SKOUT system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in adults undergoing colorectal cancer screening or surveillance. It is intended as an assistive tool, meaning the gastroenterologist remains responsible for reviewing suspected polyp areas and making all clinical judgments regarding diagnosis and treatment.
Clinical studies have shown that the SKOUT system significantly improves adenoma detection rates, with one study demonstrating a 27% relative increase in adenomas per colonoscopy without increasing unnecessary resections. However, it is indicated for white light colonoscopy only and is not intended to replace a full patient evaluation or provide primary interpretation of endoscopic procedures.
The SKOUT system is designed for seamless integration into existing clinical workflows without increasing total procedure or withdrawal time. It features smart detection of endoscopic tools, temporarily removing the bounding box to avoid obstructing the physician's view during interventions like polyp removal.
While specific details on patient data handling by the medical SKOUT system are not extensively detailed in the provided search results, general information about Iterative Health (the developer) indicates a focus on precision medicine technologies. For AI systems in healthcare, robust encryption protocols and adherence to data protection regulations are standard expectations to safeguard patient information.
Yes, the SKOUT system is not the only AI-enhanced colonoscopy device on the market; for example, the GI Genius program developed by Cosmo Pharmaceuticals and distributed by Medtronic also received FDA marketing authorization. Both systems aim to improve polyp detection by highlighting areas of interest in real-time during colonoscopies.
The provided search results do not offer specific pricing models or costs for the medical SKOUT system. Pricing for such advanced medical devices typically involves direct consultation with the distributor, Provation, and can vary based on facility size, integration needs, and contractual agreements.

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

Investors who backed SKOUT system

Funded through the company that built this tool.

Obvious Ventures
VC T1
San Francisco, United States
unknown
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Seae Ventures
VC T3
Boston, United States
$1M-$5M
Seae Ventures is a Boston-based early-stage venture capital firm investing in diverse founders building healthtech, mental health, and oral care platforms. The…
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P5 Health Ventures
VC T3
Westport, United States
unknown
P5 Health Ventures is a healthcare-focused investment firm whose name signals dedicated sector commitment, though the source data lacks an active website…
AI/ML in Healthcare Care Delivery / Tech-Enabled Services
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