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 510(k) clearance from the FDA 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 information to gastroenterologists. When a polyp is detected, the system draws attention to it on the procedure monitor using artificial intelligence by displaying a blue bounding box around it and tracking the polyp as it moves. moves on the screen. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the doctor’s view during removal.

“Our founder Jon Ng, MBBS, has long believed that technology has the ability to begin to democratize care. As a physician, he knows that technology cannot replace physicians but can certainly complement them in practice,” Shrujal Baxi, MD, MPH, Iterative Scopes CMO, wrote in a statement for MD+DI. “Pattern recognition can take years of experience to cultivate and remains central to so many diagnostic interpretations in medicine. Why not apply technology to develop algorithms to learn from colonoscopies and advance this collective knowledge through an app like SKOUT. We think this is an exciting use of computer vision.

In a prospective, randomized study published in Gastroenterology, SKOUT was reviewed at 5 academic and community centers by board-certified gastroenterologists in the United States. Patients aged 40 years and older undergoing screening or surveillance colonoscopy (≥ 3 years) were included. Patients were then randomized by endoscopist to standard colonoscopy or a computer-aided detection (CADe) device, the latter being the SKOUT device. The two primary endpoints were adenomas per colonoscopy (APC), the total number of resected adenomas 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 the eligibility criteria – 677 patients were in the standard arm and 682 were included in the CADe arm.

According to the study results, the APC increased significantly with the use of the CADe device (standard vs CADe: 0.83 vs 1.05, P=0.002; total number of adenomas, 562 vs 719) , with no decrease in PTH with the use of CADe (standard vs CADe: 71.7% vs 67.4%, P < 0.001; total number of non-neoplastic lesions, 284 vs 375). Moreover, the detection rate was 43.9% and 47.8% in the standard and CADe arms, respectively (P = 0.065).

“Importantly, in the proximal colon, SKOUT demonstrated a 44% relative increase in detection of 5-9mm polyps and a 29% relative increase in overall detection of 5-9mm polyps” , wrote the press release announcing the FDA approval.

Higher APC levels have been shown to lead to better patient outcomes, showing the importance of detection. A recent study showed that the incidence of colorectal cancer in the three years following the examination decreases with higher CPA levels.

It should be noted that according to Iterative Scopes, integrating SKOUT into existing clinical workflows does not increase total procedure or removal time. Additionally, Provation, which has 3,5000 customer institutions, including 80% of top academic systems and large healthcare systems, will act as SKOUT’s exclusive distributor to help expand its reach among leading GI-focused organizations across the country. country.

“We are excited to bring SKOUT to gastroenterology practices and look forward to hearing directly from our users about how it affects their practice,” said Baxi. “At Iterative Scopes, we believe technology is well positioned to improve the delivery of care through the use of technological pattern recognition to complement physicians’ experience with diagnostic, screening and monitoring colonoscopies.”

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