- Class IIb CE marking is a prerequisite for Median’s eyonis® LCS Software as a Medical Device marketing in Europe
- Lung cancer screening programs are already implemented in several European countries, and will be gathering pace across the continent,
- Eligible population in Europe is estimated at 20 million people
- Median previously submitted U.S. application for FDA 510(k) clearance of eyonis® LCS in May 2025 for marketing in U.S.
- On track for U.S. commercial launch before year-end and European launch in H1 2026, pending regulatory authorizations
Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, “Median” or the “Company”), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers,announced today it has filed an application for Class IIb CE marking of eyonis® LCS (Lung Cancer Screening), its AI/ML tech-based Software as a Medical Device (SaMD) for computer aided detection and diagnosis (CADe/CADx) of lung cancer in screening programs. Concurrently to CE marking, Median has also applied for ISO 13485 certification for the Quality Management System supporting the manufacturing of eyonis ® LCS.
Median Technologies applied for 510(k) clearance of eyonis® LCS with the U.S. Food and Drug Administration (FDA) on May 2025.
Both regulatory filings confirm that timetables for eyonis® LCS are on track, towards commercial launch as soon as year-end 2025 in the U.S., pending FDA 510(k) clearance expected end Q3 2025, and in H1 2026 in Europe, pending Class IIb CE marking expected in Q1 2026.
“Filing for CE marking of eyonis® LCS is yet another important step forward for Median, leveraging the Median eyonis® strong technology, clinical development and regulatory capabilities,” said Fredrik Brag, CEO and Founder of Median Technologies. “Our regulatory submissions are built on a significant volume of positive clinical data demonstrating eyonis® LCS’ safety and efficacy in REALITY and RELIVE successful pivotal studies. We are looking forward to continuing and finalizing our constructive discussions with market stakeholders, in both the U.S. and Europe, as we aim to bring eyonis® LCS to patients eligible for lung cancer screening in existing and future screening programs. Thanks to multiple institutions visits and major medical congresses attendance, our eyonis® team confirms the strong support of lung cancer key opinion leaders belonging to the pulmonology, oncology and radiology scientific bodies and societies in the U.S. and Europe. We are truly blessed with an exceptional appreciation of our highly differentiated technology, which contributes to establishing a powerful brand equity for eyonis® LCS. Additionally, our device market access strategy is already developed, ready for execution in the U.S. and tailored for specific payers to ensure maximum market penetration”.
Based on SOLACE project data, the overall eligible population in the EU is about 20 million people. Currently, Croatia and Poland have national Low Dose Computed Tomography (LDCT)-based lung cancer screening programs and many other European countries are conducting promising pilot programs.
On June 23, 2025, LDCT-based lung cancer screening received green light in Germany for eligible people covered by statutory health insurance providers, with the policy due to go into effect in April 2026. Other European countries are moving toward lung cancer screening programs implementation, including France.
In the U.S., the market opportunity includes a population of 14.5 million people, currently eligible for a LDCT lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. The eligible U.S. patient number is expected to rise in the coming years, driven by the planned broadening of the eligibility criteria.
