The US Food and Drug Administration (FDA) has cleared a lung cancer detection tool on Median Technologies’ eyonis, a suite of artificial intelligence (AI)-based software for early cancer diagnosis.
The French medtech company’s eyonis lung cancer screening (LCS) is a computer-aided detection and diagnosis (CADe/CADx) Software as a Medical Device (SaMD) that is designed to analyse imaging data generated from CT scans to assist radiologists in detecting and characterising parenchymal pulmonary nodules on the lungs.
Following the announcement of the FDA approval before stock markets opened on 9 February, Median’s Paris-listed stock climbed by 19% to €5.10 ($6.06) at market open versus a previous close of €4.28. By 15:00 CET, the company’s stock had risen by around 50%. Median Technologies has a market cap of €156m.
FDA clearance for eyonis LCS was supported by data from Median’s RELIVE (NCT06751576) pivotal trial, which met its primary endpoint, demonstrating that when used alongside a radiologist, the diagnostic achieved a statistically significant improvement of p=0.027 over a radiologist alone.
Meanwhile, according to Median, in manufacturer performance testing for a lung cancer screening reference population, eyonis LCS demonstrated 93.3% sensitivity, 92.4% specificity, and a 99.9% Negative Predictive Value (NPV).
Median Technologies’ CEO and found Fredrik Brag commented: “We believe eyonis LCS will prove to be a gamechanger for clinical teams as they manage rising screening volumes and help healthcare systems deliver high-accuracy and timely lung cancer diagnosis for eligible patients.”
Median said it plans a market rollout of eyonis LCS in the US via a combination of direct enterprise sales, strategic distribution partnerships, and integration into existing clinical environments.
Median said it will utilise the current US Centers for Medicare & Medicaid Services (CMS) reimbursement framework – the software is assigned under Medicare at a rate between $601 to $700. The company will continue working towards “broader, long-term insurance coverage”.
In January 2025, Median gained a €37.5m grant from the European Investment Bank (EIB) and €10m from an equity line with IRIS Capital Investment that it used to support its FDA filing. The company also said at the time that it would use the funds to support the receipt of a European CE mark for eyonis, which it now expects to obtain in Q2 2026.
Median’s FDA clearance proceeds the FDA clearance of RevealDX’s comparable tool for lung nodule evaluation on 3 February. The Washington-based company’s software analyses chest CT scans for lung nodules and assigns them a Malignancy Similarity Index (mSI) to help radiologists determine patient follow-up recommendations.
