{"id":48714,"date":"2022-09-22T18:02:08","date_gmt":"2022-09-22T16:02:08","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/iterative-scopes-receives-fda-clearance-for-ai-assisted-polyp-detection-device-skout\/"},"modified":"2022-09-22T18:02:08","modified_gmt":"2022-09-22T16:02:08","slug":"iterative-scopes-receives-fda-clearance-for-ai-assisted-polyp-detection-device-skout","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/iterative-scopes-receives-fda-clearance-for-ai-assisted-polyp-detection-device-skout\/","title":{"rendered":"Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT\u2122"},"content":{"rendered":"
\n

\nSKOUT\u2019s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy<\/i>\n<\/p>\n

CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–Iterative Scopes<\/a>, a pioneer in precision medicine technologies for gastroenterology, and Provation<\/a>, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT\u2122 has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance. 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. 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<\/sup>\n<\/p>\n

<\/a><\/p>\n

\nIn 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\u2019s reach among the country\u2019s top GI-focused organizations.\n<\/p>\n

\nColorectal cancer is the second leading cause of cancer-related deaths in the United States and Europe,2<\/sup> 3<\/sup> due in part to the high volumes of adenomas \u2013 approximately 26%4<\/sup> \u2013 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<\/a> showed that the incidence of colorectal cancer within three years of examination decreases with higher APC rates.5<\/sup>\n<\/p>\n

\n\u201cEven among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes,\u201d said Sloane Allebes Phillips, VP of Clinical Operations at Iterative Scopes. \u201cWe 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.\u201d\n<\/p>\n

\nSKOUT 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<\/sup> These results validate the need for technological advancements that can help improve colonoscopies, and SKOUT\u2019s artificial intelligence capabilities position it to do so.\n<\/p>\n

\n\u201cKnowing 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\u2019s FDA clearance,\u201d said Aasma Shaukat, MD, 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. \u201cConfidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients.\u201d\n<\/p>\n

\n\u201cWe 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,\u201d said Daniel Hamburger, CEO at Provation. \u201cSKOUT is a true game-changer for the field of gastroenterology, and we can\u2019t wait to start seeing its impact on patient care.\u201d\n<\/p>\n

\nSKOUT\u2019s intuitive user interface seamlessly integrates with existing clinical workflows and does not increase total procedure or withdrawal time.1<\/sup> 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\u2019s view during polyp removal.\n<\/p>\n

\nFor more information on SKOUT, visit: https:\/\/www.iterativescopes.com\/endoscopy-solutions<\/a>\n<\/p>\n

\nAbout Iterative Scopes<\/b>\n<\/p>\n

\nIterative 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, Massachusetts.\n<\/p>\n

\nAbout Provation<\/b>\n<\/p>\n

\nProvation is a leading provider of healthcare software and SaaS solutions for clinical productivity, care coordination, quality reporting, and billing. Our purpose is to empower providers to deliver quality healthcare for all. Provation\u2019s comprehensive portfolio spans the entire patient encounter, from pre-procedure through post-procedure, with solutions for physician and nursing documentation (Provation\u00ae<\/sup> MD, Provation\u00ae<\/sup> Apex, MD-Reports, Provation\u00ae<\/sup> endoPRO\u00ae<\/sup>, and Provation\u00ae<\/sup> MultiCaregiver), anesthesia documentation (#1<\/i> Best in KLAS<\/i> Provation\u00ae<\/sup> iPro), patient engagement, surgical care coordination, quality reporting, and billing capture (Provation\u00ae<\/sup> SurgicalValet\u2122), order set and care plan management (Provation\u00ae<\/sup> Order Set Advisor\u2122 and Provation\u00ae<\/sup> Care Plans), and EHR embedded clinical documentation (Provation\u00ae<\/sup> Clinic Note). Provation has a loyal customer base, serving 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. For more information about our solutions, visit provationmedical.com<\/a> and follow us on Twitter<\/a>, Facebook<\/a>, and LinkedIn<\/a>.\n<\/p>\n

\n1<\/sup> Shaukat A, Lichtenstein D, Somers S, et al. (2022). Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial<\/i>. Gastroenterology. https:\/\/doi.org\/10.1053\/j.gastro.2022.05.028<\/a>
2 <\/sup>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<\/i>. European Journal of Cancer; 157: 308-347.
\n
3 <\/sup>Rebeca S, Kimberly M, Ann Godin S. (2020). Colorectal Cancer Statistic, 2020. CA Cancer J Clin; 70:145-164.
\n
4<\/sup> 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<\/i>. Gastroenterology; 156:1661-1674.e11
\n
5<\/sup> 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<\/i>. Paper presented at: American College of Gastroenterology 2021 Annual Scientific Meeting; October 22-27, 2021; Las Vegas, Nevada.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nAriel Rapoport, Associate Director of Marketing
\n
Iterative Scopes
\n
press@iterativescopes.com<\/a>\n<\/p>\n

\nHannah Fier, Account Manager
\n
Matter Health for Iterative Scopes
\n
iterativescopes@matternow.com<\/a>\n<\/p>\n

\nTristan Galvan
\n
Director, Marketing Communications
\n
Tristan.Galvan@provationmedical.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

SKOUT\u2019s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–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 today that SKOUT\u2122 has received 510(k) clearance from … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48714","6":"format-standard","7":"category-industry"},"yoast_head":"\nIterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT\u2122 - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/iterative-scopes-receives-fda-clearance-for-ai-assisted-polyp-detection-device-skout\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT\u2122 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"SKOUT\u2019s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–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 today that SKOUT\u2122 has received 510(k) clearance from ... 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