Iterative Health
AI for gastroenterology across two product lines. SKOUT is a real time computer aided polyp detection device that received FDA 510(k) clearance in 2022 for adults undergoing colorectal cancer screening or surveillance, applying computer vision to endoscopic video to flag suspicious tissue during the procedure. In a randomized controlled trial published in Gastroenterology, SKOUT demonstrated a 27 percent relative increase in adenomas detected per colonoscopy, and the company states it was evaluated in the largest US based multicenter clinical study completed for a computer aided detection device in this category. The vendor reports the device does not extend total procedure or withdrawal time. Distribution runs through an exclusive partnership with Provation, a GI documentation vendor reporting more than 3,500 customer facilities. The second line, Clinical Trial Optimization and AI Recruitment, applies machine learning to endoscopic image scoring and patient identification for inflammatory bowel disease trials, serving life sciences sponsors rather than providers.
Capability Axes
For SKOUT the computer vision model is the device. It is the thing FDA cleared, and without it there is no product, only an endoscope. The clinical trial optimization line is likewise machine learning applied to endoscopic image scoring and patient identification.
Structurally sound by design: the model flags suspicious tissue in real time and the gastroenterologist decides and acts during the procedure. The AI cannot resect or diagnose, only draw attention, which is the appropriate autonomy ceiling for a detection aid and is reflected in the cleared indication.
A randomized controlled trial published in Gastroenterology reported a 27 percent relative increase in adenomas detected per colonoscopy, and the company states the device was evaluated in the largest US based multicenter study completed for a computer aided detection device in this category. An RCT with a published effect size on a clinically meaningful endpoint is the strongest evidence standard in this index. The vendor also reports the device does not extend procedure or withdrawal time, which addresses the practical objection to detection aids.
SKOUT holds FDA 510(k) clearance obtained in 2022 with a stated indication: adults undergoing colorectal cancer screening or surveillance. The company states the indication precisely rather than describing the product as broadly cleared, and separately identifies its clinical trial products as research services rather than regulated devices. Clear per product scoping is what this axis rewards.
No public pricing. Contact the vendor. SKOUT is distributed in the US through an exclusive partnership with Provation, which means the commercial counterparty for many buyers is the distributor rather than Iterative Health, a structural fact worth establishing early in procurement.
Narrow and precisely stated: gastroenterology, spanning colonoscopy for colorectal cancer screening and surveillance, and inflammatory bowel disease trial workflows. No claims outside GI.
Pricing
Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.
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Device sold through exclusive distribution; separate life sciences service contracts | — | — | Vendor Published |
No rate card published. SKOUT is distributed in the United States through an exclusive partnership with Provation, so the contracting counterparty for many buyers will be the distributor rather than Iterative Health. Clinical trial optimization services are contracted separately with life sciences sponsors on a different commercial basis.