Magentiq Eye vs Optellum Virtual Nodule Clinic

A sponsor-funded randomized tandem trial in The Lancet Digital Health enrolled 916 patients at 10 hospitals and found 0.70 adenomas per colonoscopy with the AI against 0.51 without (p=0.015), and an adenoma miss rate of 19% against 36% in the tandem substudy. Several authors report consultancy, stock options or equipment from Magentiq, and the abstract does not name the device. openFDA lists four Magentiq 510(k)s, from K223473 (July 25, 2023) to K260724 (April 3, 2026). For a gastroenterology group weighing polyp detection, that is a GI purchase, and Optellum's CT nodule software is a pulmonology and radiology one.

Optellum fits a pulmonology clinic or radiology reading room working up incidental lung nodules on CT. Its one clearance, K202300 (March 5, 2021), cites the QuantX De Novo as predicate and covers the LCP-CNN risk score for pulmonologists and radiologists. CPT Category III codes 0721T and +0722T are attached to it, and the vendor names Penn Medicine and Vanderbilt University Medical Center among its sites.