Iterative Health vs ScreenPoint Transpara

A sponsor-run randomized trial in Gastroenterology put SKOUT at 1.05 adenomas per colonoscopy against 0.83 with standard colonoscopy (P=.002), across 22 endoscopists at 5 centers. Adenoma detection rate went from 43.9% to 47.8% and missed significance (P=.065). openFDA lists six SKOUT 510(k)s, from K213686 (August 12, 2022) to K253664 (December 22, 2025). SKOUT works on colonoscopy video, so it is sold to gastroenterology groups and endoscopy centers. Iterative Health's home page now leads with clinical research for providers and sponsors, and the company names GI Alliance, One GI and US Heart & Vascular as strategic partners.

Colonoscopy and mammography are bought by different clinical teams. ScreenPoint's buyer is a breast screening program working with 2D and 3D mammograms, backed by eight Transpara clearances on openFDA, the latest K260898 on August 14, 2026. The MASAI trial in The Lancet Digital Health, run by Lund University, tested AI-supported screening, and the vendor says Transpara was the tool. The vendor's 29% gain in cancer detection and 44% cut in workload come from different analyses. The SKOUT page offers a demo and ScreenPoint's home page a virtual demo, and neither shows a price.