Company Spotlight: Median Technologies eyonis LCS - Risk Stratifying Lung Cancer Screening

In this Company Spotlight, we dive into the FDA 510(k) clearance for Median Technologies' eyonis LCS 1.1. We unpack how this AI tool aims to go beyond basic nodule detection by assigning malignancy risk scores on low-dose chest CTs, and what the reader study numbers reveal about false positives in clinical practice.

Key points

• Median Technologies received FDA clearance for eyonis LCS 1.1, an AI software that detects, localizes, and characterizes pulmonary nodules on low-dose Chest CT images.
• The software assigns a 10-point score to solid and part-solid nodules between 4-30 mm, while excluding pure ground glass and mediastinal lesions.
• Clearance is based on substantial equivalence to the predicate device Transpara.
• In a retrospective standalone study of 1,147 patients, the algorithm achieved a patient-level AUROC of 0.904.
• A multi-reader study of 480 patients showed aided radiologists improved their specificity to 53.59% compared to 49.45% unaided, without sacrificing sensitivity.

Source: FDA 510(k) summary K251474: Median LCS (internal name) / eyonis LCS (trade name) (1.0) (Median Technologies) - U.S. Food and Drug Administration, 2026

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: Median Technologies (mediantechnologies.com) · Product: Median LCS (internal name) / eyonis LCS (trade name) (1.0) · FDA 510(k) K251474

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-median-technologies-eyonis-lcs-risk-stratifying-lung-227df8