Imaging software developer Median Technologies has received CE marking for eyonis LCS, clearing the company's AI lung cancer screening software for commercial launch in Europe.
The CE mark classifies eyonis LCS as a Class IIb device under the EU's Medical Device Regulation. The software analyzes low-dose CT (LDCT) scans to detect and characterize pulmonary nodules, with reported performance of 93.3% sensitivity and 92.4% specificity, Median said.
The CE marking follows the U.S. Food and Drug Administration (FDA)'s 510(k) clearance of eyonis LCS in February.
