Software as a Medical Device (SaMD) developer Median Technologies (Euronext Growth Paris:ALMDT) has submitted a 510(k) application to the US Food and Drug Administration for eyonis LCS, its artificial intelligence-based software designed to aid in lung cancer screening, the company said on Wednesday.

This submission follows positive outcomes from two pivotal studies, REALITY and RELIVE, both of which met their primary endpoints.

Eyonis LCS demonstrated strong diagnostic performance in detecting and characterising lung nodules in high-risk populations. The REALITY study showed area under the curve (AUC) value of 0.904, significantly above the 0.80 benchmark. RELIVE confirmed safety and efficacy, with radiologists using eyonis LCS achieving statistically significant improvements in diagnostic accuracy.

The software is designed to support early lung cancer detection using low dose computed tomography, potentially enabling clinicians to manage larger screening volumes with improved confidence. Median anticipates US regulatory clearance in the third quarter of 2025, based on typical review timelines for radiological medical devices.

Eyonis LCS is part of Median's broader AI-powered Software as a Medical Device portfolio for early cancer diagnosis.