Software as a Medical Device (SaMD) developer Median Technologies (Euronext Growth Paris:ALMDT) announced on Monday that it has received FDA 510(k) clearance for eyonis LCS, an AI-powered software medical device for lung cancer screening using low-dose CT scans.

According to Median, eyonis LCS is the first AI-based device authorised in the United States to both detect and characterise lung cancer, supporting earlier diagnosis while reducing false positives and unnecessary follow-up procedures.

In manufacturer testing, eyonis LCS achieved 93.3% sensitivity, 92.4% specificity, and a 99.9% negative predictive value, enabling high diagnostic confidence for clinicians.

The clearance supports deployment across US lung cancer screening programmes serving an estimated 14.5 million eligible individuals, with adoption supported by an existing NT-APC 1508 reimbursement pathway.

Median plans to commercialise the software through direct sales, partnerships, and integration into hospital PACS systems under the current CMS framework. The company is also advancing European regulatory approval and expects CE marking in the second quarter of 2026.