• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

Assisted Polyp Detection Device Receives FDA Clearance

by Syed Hamza Sohail 09/22/2022 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print
AI-Assisted Polyp Detection Device Receives FDA Clearance

What You Should Know:

– Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced recently that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance.

– The device was evaluated in the largest U.S.-based multicenter clinical study for a computer-aided polyp detection (CADe) device completed to date, which determined that SKOUT significantly improved overall adenoma detection in screening and surveillance colonoscopy compared to standard colonoscopy

Enabling Physicians to Detect Pre-Cancerous Lesions in the Colon Accurately

SKOUT, a real-time computer-aided polyp detection device developed by Iterative Scopes, uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists. In March 2021, Provation and Iterative Scopes entered a partnership focused on delivering artificial intelligence-based solutions to healthcare providers and researchers. Provation is a market leader in gastrointestinal (GI) documentation, with more than 3,500 customer facilities including 80% of the top academic and large health systems, and the company will act as an exclusive distributor of SKOUT to help broaden the technology’s reach among the country’s top GI-focused organizations.

Colorectal cancer is the second leading cause of cancer-related deaths in the United States and Europe,2 3 due in part to the high volumes of adenomas – approximately 26% – that endoscopists miss when conducting a colonoscopy. In its registration trial, SKOUT was found to improve adenoma detection, as measured by adenomas per colonoscopy (APC). Furthermore, increased detection was not limited to diminutive polyps. Higher APC rates have been shown to lead to improved patient outcomes; a recent study showed that the incidence of colorectal cancer within three years of examination decreases with higher APC rates.

“Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes,” said Sloane Allebes Phillips, VP of Clinical Operations at Iterative Scopes. “We are enthusiastic about the fact that even gastroenterologists with an already high baseline rate of adenoma detection demonstrated an improvement with SKOUT. Now that SKOUT is FDA-cleared, clinicians will be able to better detect adenomas with more efficiency, and ultimately change the standard of gastrointestinal care.”

SKOUT 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 demonstrated a 27% relative increase in the detection of adenomas per colonoscopy, with an average of one additional adenoma resected for every 4.5 patients examined. Importantly, in the proximal colon, SKOUT demonstrated a 44% relative increase in 5-9 mm polyp detection, and a 29% relative increase in 5-9 mm polyp detection overall. These results validate the need for technological advancements that can help improve colonoscopies, and SKOUT’s artificial intelligence capabilities position it to do so.

SKOUT’s intuitive user interface seamlessly integrates with existing clinical workflows and does not increase total procedure or withdrawal time.1 When a potential polyp is detected, the system calls attention to the polyp on the procedure monitor by drawing a blue bounding box around it and tracking the polyp as it moves on the screen. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the physician’s view during polyp removal.

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: Artificial Intelligence, Box, cancer, clinical workflows, FDA, FDA Clearance, Health Systems, Phillips, physicians, Precision Medicine, Premier

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

2025 EMR Software Pricing Guide

2025 EMR Software Pricing Guide

Featured Interview

Kinetik CEO Sufian Chowdhury on Fighting NEMT Fraud & Waste

Most-Read

2019 MedTech Breakthrough Award Category Winners Announced

MedTech Breakthrough Announces 2025 MedTech Breakthrough Award Winners

WeightWatchers Files for Bankruptcy to Eliminate $1.15B in Debt

WeightWatchers Files for Bankruptcy to Eliminate $1.15B in Debt

KLAS: Epic Dominates 2024 EHR Market Share Amid Focus on Vendor Partnership; Oracle Health Sees Losses Despite Tech Advances

KLAS: Epic Dominates 2024 EHR Market Share Amid Focus on Vendor Partnership; Oracle Health Sees Losses Despite Tech Advances

'Cranky Index' Reveals EHR Alert Frustration Peaks Midweek, Highest Among Admin Staff

‘Cranky Index’ Reveals EHR Alert Frustration Peaks Midweek, Highest Among Admin Staff

Madison Dearborn Partners to Acquire Significant Stake in NextGen Healthcare

Madison Dearborn Partners to Acquire Significant Stake in NextGen Healthcare

Wandercraft Begins Clinical Trials for Physical AI-Powered Personal Exoskeleton

Wandercraft Begins Clinical Trials for Physical AI-Powered Personal Exoskeleton

Chipiron Secures $17M to Transform MRI Access with Portable Scanner

Chipiron Secures $17M to Transform MRI Access with Portable Scanner

Abbott to Integrate FreeStyle Libre Glucose Data with Epic EHR

Abbott to Integrate FreeStyle Libre Glucose Data with Epic EHR

5 Ways New Trump Administration Tariffs Are Impacting U.S. Healthcare Now

5 Ways Trump Administration Tariffs Are Impacting U.S. Healthcare Now

iCAD, GE HealthCare Integrate to Advance Breast Cancer Detection with AI

RadNet to Acquire iCAD for $103M in All-Stock Transaction

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |