Median Technologies: eyonis achieves REALITY study objectives

On August 29, 2024, Median Technologies announced that its eyonis™ LCS software met all endpoints of the REALITY pivotal study. In particular, the software achieved an area under the curve (AUC) of 0.90, well above the 0.80 threshold required for regulatory approval.

The study's secondary results are also positive, with statistically significant data across all nine endpoints. Topline results from the second pivotal study, RELIVE, are expected in the first quarter of 2025.

With these advances, Median plans to file applications for marketing authorization with the US FDA and for EU CE marking in the first half of 2025. This could revolutionize the early detection of lung cancer.