The US Food and Drug Administration (FDA) has granted marketing clearance to Eyonis LCS, an artificial intelligence-powered software program to assist with lung cancer screening. 

The software was cleared under the FDA’s 510(k) rubric as “software as a medical device,” Median Technologies, the French company behind Eyonis LCS, announced in a press release.

The agency has already given 510(k) clearance to several other lung cancer screening AI programs, but Median said its program is the first to combine both tumor detection and diagnosis assistance in the same product.

Eyonis LCS analyzes low-dose CT scans to characterize nodules and produce a malignancy risk score. Radiologists use the information to inform their own decisions. The goal, according to Median, is to help radiologists catch cancers earlier while also reducing false positives and operational burden. The software is integrated directly into hospitals’ existing imaging systems.

Clearance was based primarily on two studies. The first, REALITY, retrospectively validated Eyonis LCS in 1147 patients with 2275 benign nodules and 371 biopsy-confirmed cancers on low-dose CT screening. The software achieved a patient-level area under the curve (AUC) of 0.904 (95% CI, 0.881-0.926) for correctly detecting and characterizing nodules, with 80.1% sensitivity and 86.6% specificity overall.

In the second study, RELIVE, 16 experienced thoracic radiologists reviewed 480 low-dose CT scans (160 cancers, 320 benign nodules) both with and without Eyonis LCS. The program provided a small but statistically significant boost in performance, increasing average AUC by 0.016 (P = .027), the company reported last year.

The system is also being developed for liver, pancreatic, colon, and prostate cancer imaging, Median said.

A company spokesperson told Medscape Medical News that Eyonis LCS is marketed as a service, but the cost of the license is “more than offset by the 2026 CMS reimbursement of $650 per screen.”

The company expects its first US sites to be operational in 90 days, the spokesperson said.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com