French imaging software developer Median Technologies is highlighting results from the RELIVE clinical trial regarding its AI-based CADe/CADx software as a medical device for lung cancer screening, eyonis LCS.
The software can improve clinicians' diagnostic accuracy in analyzing low-dose CT lung cancer screening scans, the company said. RELIVE data showed that eyonis LCS achieved statistically significant diagnostic improvement over radiologist reading alone (p = 0.027).
The company plans to file for U.S. Food and Drug Administration (FDA) 510(k) clearance and European Union CE marking in the second quarter of this year, it said.
