SKOUT® system

by Iterative Scopes  · Based in United States → — Empowering exceptional GI care through AI-enabled technology and services to standardize care and expand access to clinical research.
Gastroenterology

Contact for details
Regulatory Status Disclosed

Overview

The SKOUT® system by Iterative Scopes (also known as Iterative Health) is an advanced artificial intelligence (AI) and computer-aided detection (CADe) system designed to assist gastroenterologists in the real-time detection of potential colorectal polyps during colonoscopy examinations. Utilizing sophisticated computer vision technology, SKOUT® processes high-definition endoscopic video feeds and provides an informational visual aid, typically a blue bounding box, around suspicious tissues on the endoscopic monitor. The system is engineered to integrate seamlessly into existing clinical workflows without increasing total procedure or withdrawal time. Beyond polyp detection, Iterative Scopes also applies its AI capabilities to standardize disease severity characterization for inflammatory bowel disease (IBD) and to accelerate patient identification and enrollment for gastrointestinal clinical trials.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time AI-powered polyp detection during colonoscopy
  • Advanced computer vision technology for suspicious tissue recognition
  • Visual aid (blue bounding box) on endoscopic monitor for polyp localization
  • Seamless integration into existing clinical workflows
  • Does not impact total procedure or withdrawal time
  • Smart detection of endoscopic tools to keep visual field clear during resection
  • Demonstrated improvement in adenoma detection rates (e.g., 27% relative increase in APC)
  • Enhanced sensitivity for clinically significant polyps and doubled detection speed (latest version)
  • Aids in standardizing disease severity characterization for IBD

Use Cases

  • Colorectal cancer screening and surveillance colonoscopies
  • Assisting gastroenterologists with real-time polyp detection
  • Improving adenoma detection rates to enhance patient outcomes
  • Standardizing endoscopic interpretation for inflammatory bowel disease (IBD)
  • Accelerating patient identification and enrollment for GI clinical trials
  • Reducing physician fatigue during high-volume colonoscopy procedures

What Physicians Need to Know

Evidence Base
SKOUT is an AI-driven medical device utilizing advanced computer vision technology. It has received FDA 510(k) clearance in the U.S. and a CE Mark in Europe. Its efficacy is supported by clinical studies performed by Iterative Scopes, including a randomized controlled trial published in 'Gastroenterology'.
Clinical Validation Studies
A prospective, randomized, multicenter study involving over 1,350 participants across 5 academic and community centers in the U.S. demonstrated a 27% relative increase in the detection of adenomas per colonoscopy (APC) overall. Specifically, it showed a 44% relative increase in 5-9mm polyp detection in the proximal colon and a 33.5% relative increase in Adenoma Detection Rate (ADR) overall, with a 74.0% relative increase in screening exams. The study also indicated no significant increase in unnecessary polyp resections or impact on procedure or withdrawal time.
Alert Fatigue Management
The system is designed to mitigate alert fatigue through 'smart detection' of endoscopic tools; the bounding box around a detected polyp automatically disappears when a medical tool enters the frame, preventing visual obstruction. A case study noted 'minimal false positives, so it wasn't distracting'. SKOUT is intended to augment, not replace, physician judgment.
Override Rate Data
Specific override rate data is not explicitly provided. However, the system is designed as an assistive tool, and the gastroenterologist remains responsible for reviewing suspected polyp areas and confirming their presence or absence based on their medical judgment.
Guideline Update Frequency
The frequency of guideline updates for the SKOUT system itself is not specified in the provided information. As an AI-driven device, its algorithms are subject to ongoing development and maintenance, aligning with regulatory clearances.
Clinical Workflow Integration
SKOUT is designed for seamless integration into existing clinical workflows without increasing total procedure or withdrawal time. It allows endoscopists to switch between a standard video feed and an enhanced video with the SKOUT display.
Physician Tip

Physicians should view SKOUT as a valuable 'second set of eyes' to augment their perception during colonoscopies, particularly for difficult-to-detect or flat lesions. Remember that it is an assistive tool and does not replace your clinical judgment for diagnosis or treatment decisions. Utilize its real-time feedback to enhance detection while maintaining your established workflow, as it is designed not to impact procedure time. Be aware that the system does not differentiate between adenomatous or neoplastic polyps, so your medical expertise is crucial for subsequent clinical decisions.

SKOUT is designed for seamless integration with existing colonoscopy equipment and video feeds. Iterative Scopes has partnered with Provation, a provider of clinical productivity and workflow automation solutions, for exclusive distribution, suggesting potential integration pathways with Provation's broader suite of healthcare software for academic centers, health systems, and gastroenterology-focused practices.

Details

Category Gastroenterology AI
Pricing Contact for details — Enterprise pricing; contact sales for a quote.
DeploymentSoftware-based system integrated with endoscopy equipment
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The SKOUT® system has received FDA 510(k) clearance (K241508 on July 3, 2024, for a modified version, and earlier clearance in September 2022 for SKOUT™) as a computer-aided detection tool to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.

Integrations
EHR Not specified
Specialties Gastroenterology

What the Web Says

SKOUTu00ae system by Iterative Health is an AI-powered computer-aided detection (CADe) tool designed to assist gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations. It provides real-time feedback by highlighting suspicious areas with a bounding box, aiming to improve adenoma detection rates (ADR) and ultimately reduce the incidence of colorectal cancer. The system is intended to augment, not replace, physician judgment and existing clinical workflows.

Overall: Positive

Strengths

  • Increased adenoma detection rate (ADR), with studies showing a 27% relative increase in adenomas per colonoscopy.
  • Particularly effective at detecting difficult-to-see, flat, and sessile polyps, especially in the proximal colon.
  • Seamlessly integrates with existing clinical workflows and does not increase total procedure or withdrawal time.
  • Low rate of false positives, minimizing distraction for physicians.
  • Can help maintain high-quality procedures throughout the day, potentially reducing physician fatigue.
  • FDA-cleared for use in adult patients undergoing colorectal cancer screening or surveillance.

Limitations

  • Some physicians report that while helpful, it may not significantly change practice for those with already high adenoma detection rates.
  • Potential for over-reliance on the software notification rather than clinical judgment, which could lead to false positives or negatives.
  • One physician on Reddit mentioned that while the data supports these systems, they are mixed on how much it changes their personal practice.
  • The system is an assistive tool and not intended to replace a full patient evaluation, primary interpretation of endoscopic procedures, medical diagnosis, or treatment recommendations.
  • Only indicated for white light colonoscopy.

Based on reviews from: Iterative Health (Official Website), FDA (U.S. Food and Drug Administration), BioSpace, AiThority, Obvious Ventures, Reddit (r/Gastroenterology)

Last updated: 2026-07-18

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Press & Coverage

Business Wire
Unio Specialty Care Implements Iterative Health's SKOUTu00ae to Bring Advanced AI-Enhanced Colorectal Cancer Screenings to California
Unio Specialty Care has partnered with Iterative Health to deploy SKOUT AI technology across California, aiming to enhance colonoscopies for colorectal cancer screening. SKOUT now boasts a ~40% increase in sensitivity for clinically significant polyps and nearly doubled detection speed.
2025-01
American Journal of Gastroenterology
S549 Comparative Efficacy of SKOUT and GI Genius: A Pilot Study of Artificial Intelligence-Assisted Polyp Detection During Colonoscopy
This study compared the real-world performance of SKOUT and GI Genius AI systems for polyp detection during colonoscopies, finding both improved detection with SKOUT showing slightly higher adenoma detection rates (ADR) and adenomas per colonoscopy (APC).
2025-10
Obvious Ventures
AI for the GI - Obvious Ventures
This article highlights Iterative Health's mission to provide healthcare access through AI-assisted tools like SKOUT, which is FDA-cleared and clinically proven to increase polyp detection by 27%.
2023-10
BioSpace
Iterative Health Announces Upcoming U.S. Availability of SKOUTu00ae: Real-Time AI for Polyp Detection
Iterative Health announced the upcoming commercial availability of SKOUT, a real-time AI for polyp detection, in the second quarter of 2023, indicated as a computer-aided detection tool to assist endoscopists during colonoscopy examinations.
2023-05
MD+DI
AI-Assisted Polyp Detection Device SKOUT Nabs FDA Nod
Iterative Scopes' SKOUT received FDA 510(k) clearance for adults undergoing colorectal cancer screening or surveillance, demonstrating statistically significant improvements in identifying polyps.
2022-09
Medical Product Outsourcing
FDA Clears AI-Assisted Polyp Detection Device - Medical Product Outsourcing
The FDA granted 510(k) clearance to Iterative Scopes' SKOUT device, a real-time computer-aided polyp detection device that significantly improved overall adenoma detection in screening and surveillance colonoscopy.
2022-10
Business Wire
Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUTu2122
Iterative Scopes announced that its SKOUTu2122 device received 510(k) clearance from the FDA for adults undergoing colorectal cancer screening or surveillance, with clinical trials showing a 27% relative increase in adenomas per colonoscopy.
2022-09
BioSpace
Iterative Scopes CE Marks SKOUT, its Innovative AI-Based Medical Device for Potential Colorectal Polyps Detection
Iterative Scopes announced that its SKOUT medical device received CE Mark certification, enabling its distribution and marketing in Europe as a real-time AI-driven tool for detecting colorectal polyps during colonoscopy examinations.
2021-11

Videos

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Frequently Asked Questions

The SKOUTu00ae system is a software device designed to integrate seamlessly into existing clinical workflows during colonoscopy examinations, providing real-time, AI-assisted detection of potential colorectal polyps. It acts as a computer-aided detection tool by displaying a bounding box around suspicious areas on the endoscopic monitor, aiming to augment the gastroenterologist's perception. However, it is crucial to understand that SKOUTu00ae is an assistive tool and does not replace the physician's medical judgment, a full patient evaluation, or provide primary interpretations, diagnoses, or treatment recommendations.
The SKOUTu00ae system has received FDA 510(k) clearance for use in adults undergoing colorectal cancer screening or surveillance. This clearance indicates that the device is safe and effective for its intended use as a computer-aided detection tool.
Several other AI-assisted polyp detection systems have been developed and approved for use worldwide. Notable alternatives include GI Genius, ENDO-AID, EndoAngel, and CADDIE. These systems also aim to improve polyp detection during colonoscopies using computer-aided detection technologies.
The SKOUTu00ae system is strictly an assistive tool and is not intended to replace a physician's medical judgment, provide primary interpretations, or make diagnoses or treatment recommendations. User over-reliance on the software's notifications rather than their own clinical decisions could potentially lead to false positives or false negatives. Additionally, the system is indicated for white light colonoscopy only.
Clinical studies have shown that the SKOUTu00ae system can significantly improve adenoma detection rates (ADR) and adenomas per colonoscopy (APC). For instance, it demonstrated a 27% relative increase in the detection of adenomas per colonoscopy in one randomized controlled trial. Importantly, these improvements were achieved without significantly increasing total procedure or withdrawal time.
Specific pricing details for the SKOUTu00ae medical system are not publicly disclosed in the available information. Typically, medical device acquisition involves direct consultation with the manufacturer, Iterative Health, or its exclusive distributor, Provation, to discuss pricing models, which may include subscription options, capital equipment purchases, or per-procedure fees. Interested practices would generally contact their sales representatives for a customized quote.

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SKOUT Software
Iterative Scopes
Gastroenterology AI
SKOUT Software by Iterative Scopes is an FDA-cleared AI-powered computer-aided detection (CADe) system that assists gastroenterologists in real-time polyp detection during colonoscopies, improving colorectal cancer screening and surveillance.

View company profile →

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

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