EU CE mark authorizes Median’s AI lung-screening software for clinical use
Now Possible · Friday, 11 September 2026
Why it matters
This moves AI-assisted lung-nodule detection and characterization from a validated product claim toward legally marketable clinical use in Europe, alongside the U.S. clearance reported earlier in 2026. It is not yet ordinary-patient access: the article gives no evidence of hospital adoption, reimbursement, procurement, or routine use, and access will depend on screening programs and local healthcare systems.
What happened
Median Technologies’ eyonis LCS received CE marking as a Class IIb medical device under the EU Medical Device Regulation, authorizing its use in the European market. The software analyzes low-dose CT scans, detects lung nodules, and classifies them as probably benign, suspicious, or very suspicious to support clinician decisions in lung-cancer screening. Median reports 93.3% sensitivity and 92.4% specificity, plus estimated reductions of 68% in false positives and 66% in false negatives, but those figures are company-reported and the authorization itself does not establish deployment across European screening services.
Previously
Apr 2026 — Germany launched a nationwide lung-cancer screening program using low-dose CT, according to Medical Product Outsourcing.(Medical Product Outsourcing)
Feb 2026 — The U.S. Food and Drug Administration cleared Median Technologies’ eyonis LCS for the U.S. market, according to Medical Product Outsourcing.(Medical Product Outsourcing)
2026 — Japan’s Ministry of Health, Labour and Welfare approved sevabertinib for HER2-mutated non-small-cell lung cancer, including first-line use.(Bayer via MarketScreener)
Players & places
- Median Technologies
- European Union