Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

SKOUT’s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy

Excerpt from the Press Release:

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™ 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

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%⁴ – that endoscopists miss when conducting a colonoscopy.

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