FDA Clears AI-Assisted Polyp Detection Device

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Iterative Scopes’ SKOUT device.

Developed by Iterative Scopes, SKOUT is a real-time computer-aided polyp detection device that uses advanced computer vision technology to recognize suspicious tissue and provide real-time feedback to gastroenterologists. 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.¹

“We are thrilled that our partner Iterative Scopes has received FDA clearance for their AI-Assisted Polyp Detection device, SKOUT. We have been very impressed with its study results and are eager to share our vision for integrating this technology into our solutions,” Provation CEO Daniel Hamburger aIS. “SKOUT is a true game-changer for the field of gastroenterology, and we can’t wait to start seeing its impact on patient care.”
 
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 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%⁴—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.⁵
 
“Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes,” said Sloane Allebes Phillips, vice president 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.¹ These results validate the need for technological advancements that can help improve colonoscopies, and SKOUT’s artificial intelligence capabilities position it to do so.
 
“Knowing that patients can walk away from their appointment with the confidence that they received a high quality and detailed colonoscopy is what excites us most about SKOUT’s FDA clearance,” said Aasma Shaukat, M.D., MPH, Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, and a primary investigator on the SKOUT registration study. “Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients.”
 
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.

Iterative Scopes is a pioneer in the application of artificial intelligence-based precision medicine for gastroenterology with the aim of helping to optimize clinical trials investigating treatment of inflammatory bowel disease (IBD). The technology is also designed to potentially enhance colorectal cancer screenings. Its powerful, proprietary artificial intelligence and computer vision technologies have the potential to improve the accuracy and consistency of endoscopy readings. Iterative Scopes is initially applying these advances to impact polyp detection for colorectal cancer screenings and working to standardize disease severity characterization for inflammatory bowel disease. Longer term, the company plans to establish more meaningful endpoints for GI diseases, which may be better predictors of therapeutic response and disease outcomes. Spun out of MIT (Massachusetts Institute of Technology) in 2017, the company is based in Cambridge, Mass.
 
Provation provides healthcare software and SaaS solutions for clinical productivity, care coordination, quality reporting, and billing. Provation’s portfolio spans the entire patient encounter, from pre-procedure through post-procedure, with solutions for physician and nursing documentation (Provation MD, Provation Apex, MD-Reports, Provation endoPRO, and Provation MultiCaregiver), anesthesia documentation, patient engagement, surgical care coordination, quality reporting, and billing capture (Provation SurgicalValet), order set and care plan management (Provation Order Set Advisor and Provation Care Plans), and EHR embedded clinical documentation (Provation Clinic Note). Provation serves more than 5,000 hospitals, surgery centers, and medical offices, and 700 physician groups globally, including 19 of the top 20 U.S. hospitals. In 2021, Provation was acquired by Fortive Corporation, a Fortune 1000 company that builds essential technology and accelerates transformation in high-impact fields like workplace safety, engineering, and healthcare. 

References 
¹ Shaukat A, Lichtenstein D, Somers S, et al. (2022). Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. https://doi.org/10.1053/j.gastro.2022.05.028
² Dyba T, Randi G, Bray F, et al. (2021). The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. European Journal of Cancer; 157: 308-347.
³ Rebeca S, Kimberly M, Ann Godin S. (2020). Colorectal Cancer Statistic, 2020. CA Cancer J Clin; 70:145-164.
⁴ Zhao S, Wang S, Pan P, et al. (2019). Magnitude, risk factors, and factors associated with adenoma miss rate of tandem colonoscopy: a systematic review and meta-analysis. Gastroenterology; 156:1661-1674.e11
⁵ Anderson J, Hisey W, Robinson C, et al. (2021). Mean adenomas per colonoscopy is inversely associated with post colonoscopy colorectal cancers: data from the New Hampshire Colonoscopy Registry validating this quality measure. Paper presented at: American College of Gastroenterology 2021 Annual Scientific Meeting; October 22-27, 2021; Las Vegas, Nevada.