AI-Assisted Polyp Detection Device SKOUT Nabs FDA Nod

Iterative Scopes, a precision medicine technology company focused on gastroenterology, and Provation, a software and SaaS provider of clinical productivity and workflow automation solutions, recently announced that the detection tool, SKOUT has received FDA 510(k) clearance for adults undergoing colorectal cancer screening or surveillance. SKOUT is a real-time computer-aided detection device that uses advanced computer vision technology designed to recognize suspicious tissue and provide feedback to gastroenterologists. When a polyp is detected, the system calls attention to it on the procedure monitor using artificial intelligence by showing 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 physicians view during removal.

“Our founder Jon Ng, MBBS, has long believed that technology has the ability to start to democratize care. As a physician, he knows that technology cannot replace physicians but can definitely complement them in practice,” wrote Shrujal Baxi, MD, MPH, Iterative Scopes CMO, in a statement for MD+DI. “Pattern recognition can take years of experience to cultivate and remains at the core of so much diagnostic interpretation in medicine. Why not apply technology to develop algorithms to learn from colonoscopies and bring forward that collective knowledge through an application like SKOUT. We believe it is an exciting use of computer vision.”

In a randomized, prospective study published in Gastroenterology, SKOUT was examined at 5 academic and community centers by United States board-certified gastroenterologists. Patients aged 40 years and older scheduled for screening or surveillance (≥3 years) colonoscopy were included. The patients were then randomized by endoscopist to a standard or computer-aided detection device (CADe) colonoscopy, the latter of which was noted to be the SKOUT device. The two primary endpoints were adenomas per colonoscopy (APC), the total number of adenomas resected divided by the total number of colonoscopies; and true histology rate (THR), the proportion of resections with clinically significant histology divided by the total number of polyp resections. Of the 1440 participants initially enrolled – and after excluding those who did not meet eligibility criteria – 677 patients were in the standard arm and 682 were included in the CADe arm.

According to study results, APC increased significantly with the use of the CADe device (standard vs. CADe: 0.83 vs. 1.05, P = .002; total number of adenomas, 562 vs. 719), with no decrease in THR with CADe use (standard vs. CADe: 71.7% vs. 67.4%, P < .001; total number of non-neoplastic lesions, 284 vs. 375). Additionally, detection rate was 43.9% and 47.8% in the standard and CADe arms, respectively (P = .065).

“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,” wrote the press release announcing the FDA approval.

Higher APC rates have been shown to lead to improved patient outcomes, showing the importance of detection. A recent study showed that the incidence of colorectal cancer within three years of examination decreases with higher APC rates.

Of note, according to Iterative Scopes, the integration of SKOUT into existing clinical workflows does not increase total procedure or withdrawal time. Additionally, Provation, which boasts 3,5000 customer facilities including 80% of top academic and large healthcare systems, will act as an exclusive distributer of SKOUT to help broaden its reach among the country’s top GI-focused organizations.

“We are excited to bring SKOUT to gastroenterology practices and look forward to hearing directly from our users on how it is impacting their practice,” Baxi said. “At Iterative Scopes, we believe that technology is well poised to enhance care delivery through the use of tech-enabled pattern recognition to complement physician experience with diagnostic, screening, and surveillance colonoscopies.”