Median Technologies: Green Light from FDA for its Pulmonary AI
Median Technologies announces the commercial launch of its eyonis® Lung Cancer Screening (LCS) software in the United States following the FDA 510(k) clearance. The company is also continuing the CE marking process in Europe, with a decision expected in the second quarter of 2026.
FDA Approval and Commercial Launch
Median Technologies has received FDA 510(k) clearance for eyonis® LCS, a medical device software based on artificial intelligence designed for the detection and characterization of pulmonary nodules in low-dose thoracic scans. The commercial launch of the product is underway in the United States. In Europe, the company is continuing the regulatory process for CE marking, with a decision expected in the second quarter of 2026. Obtaining this certification could trigger the commercial deployment of eyonis® LCS in Europe as early as this year.
Showcasing at the European Congress of Radiology
Median Technologies is presenting eyonis® LCS at the European Congress of Radiology (ECR) 2026, which is being held in Vienna from March 4 to 8, 2026. The eyonis® team welcomes participants at booth #AI-16 and is involved in several sessions, including two industry presentations and one scientific presentation focusing on artificial intelligence assistance in assessing the risk of pulmonary nodules. The class IIb medical device software is showcased as a tool to assist radiologists in enhancing the efficiency and consistency of lung cancer screening programs.
