Imaging software developer Median Technologies has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its eyonis LCS, an AI-based detection and diagnosis software as a medical device (SaMD) for lung cancer screening.
The software identifies and characterizes lung cancer on low-dose CT scans, with 93.3% sensitivity, 92.4% specificity, and 99.9% negative predictive value, and a false positive rate of one per 1,000 exams, according to the firm. It can be integrated into healthcare systems' PACS, it said.
Median will provide further details regarding the commercial launch of eyonis LCS in the coming weeks and plans to continue along the European Union regulatory pathway toward CE marking.
![Images show the pectoralis muscles of a healthy male individual who never smoked (age, 66 years; height, 178 cm; body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], 28.4; number of cigarette pack-years, 0; forced expiratory volume in 1 second [FEV1], 97.6% predicted; FEV1: forced vital capacity [FVC] ratio, 0.71; pectoralis muscle area [PMA], 59.4 cm2; pectoralis muscle volume [PMV], 764 cm3) and a male individual with a smoking history and chronic obstructive pulmonary disorder (COPD) (age, 66 years; height, 178 cm; BMI, 27.5; number of cigarette pack-years, 43.2, FEV1, 48% predicted; FEV1:FVC, 0.56; PMA, 35 cm2; PMV, 480.8 cm3) from the Canadian Cohort Obstructive Lung Disease (i.e., CanCOLD) study. The CT image is shown in the axial plane. The PMV is automatically extracted using the developed deep learning model and overlayed onto the lungs for visual clarity.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/03/genkin.25LqljVF0y.jpg?auto=format%2Ccompress&crop=focalpoint&dpr=2&fit=crop&h=167&q=70&w=250)
