Median Technologies has received CE marking for its eyonis LCS, an AI-based Software as a Medical Device, under the European Medical Device Regulation (MDR 2017/745).
The designation enables the company to commercialise eyonis LCS across the European Economic Area.
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The CE marking was granted by the French notified body GMED, recognising the device as compliant with the regulatory standards for patient safety and clinical efficacy required for a Class IIb medical device.
eyonis LCS is intended to support clinicians in the detection and characterisation of lung parenchymal nodules on low-dose computed tomography (LDCT) scans, potentially aiding with early lung cancer diagnosis, risk stratification, and clinical management decisions.
The approval follows the previous clearance of eyonis LCS by the US Food and Drug Administration (FDA) in February 2026.
The device’s dual approval expands its availability to address challenges in lung cancer screening, particularly the high rates of false positives and false negatives that affect current screening efforts.
Median Technologies founder and CEO Fredrik Brag said: “Receiving CE marking is a critical step in our mission to make earlier, more accurate lung cancer diagnosis accessible to more patients eligible for lung cancer screening in Europe.
“Several European nations have already launched lung cancer screening programmes and our AI-based eyonis LCS SaMD was developed to aid earlier detection and diagnosis of lung cancer, when treatment is more likely to be successful, helping patients gain faster access to potentially life-saving therapies.”
The company reports that eyonis LCS is the first to combine computer aided detection and diagnosis within the LDCT screening pathway.
Internal data cited by Median Technologies indicate a 93.3% sensitivity and 92.4% specificity for the device, compared to 80.3% sensitivity and 76.4% specificity reported for traditional radiologist screening.
