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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Median Technologies' Eyonis AI Software for Lung Cancer Screening CT

The French company's eyonis LCS detects and characterizes lung nodules on low-dose CT; its FDA summary reports a smaller reader-study gain than the headline figures in its release.

By News DeskFebruary 9, 20262 min read
Line illustration of a CT scanner with its patient table
An illustration of a CT scanner from the NIH BioArt collection. Not a scanner or software from Median Technologies. Ryan Kissinger/NIAID, public domain, via Wikimedia Commons · Public domain
FDA cleared510(k) · K251474FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • FDA records list eyonis LCS as 510(k) K251474, found substantially equivalent on February 6, 2026; Median announced the clearance on February 9.
  • In the pivotal reader study described in the FDA summary, 16 U.S. radiologists' AUC rose from 0.8276 unaided to 0.8434 with the software, a statistically significant gain.
  • Median plans to sell the software through direct sales and distribution partners and to bill under existing Category III CPT codes 0721T and 0722T.

Median Technologies said on February 9 that the U.S. Food and Drug Administration has cleared eyonis LCS, its AI software for detecting and characterizing lung nodules on low-dose CT scans taken for lung cancer screening, in a press release. The company, based in Sophia Antipolis, France, said it is the first end-to-end detection and diagnosis device FDA cleared specifically for lung cancer screening.

FDA records, read through the agency's openFDA 510(k) database, list the device as K251474, a traditional 510(k) received on May 13, 2025 and found substantially equivalent on February 6, 2026, under product code QDQ for computer-assisted detection and diagnosis software for lesions suspicious for cancer.

How it works and what FDA reviewed

According to the 510(k) summary, the software has no viewer of its own. It processes low-dose CT images and returns a report listing nodules as probably benign, suspicious or very suspicious, each with a malignancy risk score. The predicate device is ScreenPoint Medical's Transpara software, which falls under the same regulation but, the summary says, differs in target organ and disease.

In a standalone test on 1,147 patients from seven datasets in Europe and the United States, the summary reports a patient-level AUROC of 0.904, with 84.5% sensitivity and 80.25% specificity at the pre-set operating threshold. In the pivotal multi-reader study, 16 U.S. board-certified radiologists read 480 patient images with and without the software. Their image-level AUC rose from 0.8276 unaided to 0.8434 aided, a difference of 0.0158 (p = 0.0277), meeting the study's primary objective.

Median's release cites different figures: 93.3% sensitivity, 92.4% specificity and a 99.9% negative predictive value, which it describes as the results of manufacturer performance testing on a lung cancer screening reference population. Medical Device Network reported the same figures as company data and said the clearance was supported by the RELIVE pivotal trial (NCT06751576).

Commercial plans

Median said it will sell eyonis LCS in the United States through direct enterprise sales, distribution partnerships and integration into existing clinical environments, with commercial launch details to follow in the coming weeks. It said AI-driven CT tissue characterization is paid under Category III CPT codes 0721T and 0722T, both assigned to New Technology APC 1508, with Medicare payments of $601 to $700, and that it is working toward broader insurance coverage.

“We are now fully positioned to execute our go-to-market strategy and deploy eyonis® LCS at scale,” said Fredrik Brag, Median's chief executive and founder.

Median's Paris-listed shares rose 19% at the open on February 9 and were up around 50% by mid-afternoon, Medical Device Network reported. The company said it expects CE marking in Europe in the second quarter of 2026.

Sources

  1. Median Technologies receives FDA 510(k) clearance for eyonis LCS, the first AI tech-based detection and diagnosis device for lung cancer screening, Median Technologies, February 9, 2026
  2. 510(k) record K251474: eyonis LCS (openFDA data; facts cited were in the February 6, 2026 decision record), U.S. Food and Drug Administration (openFDA), February 6, 2026
  3. K251474 clearance letter and 510(k) summary, eyonis LCS, U.S. Food and Drug Administration, February 6, 2026
  4. FDA clears Median Technologies' lung nodule evaluation software, Medical Device Network, February 9, 2026