{"id":843201,"date":"2026-09-10T18:18:09","date_gmt":"2026-09-10T18:18:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/843201\/"},"modified":"2026-09-10T18:18:09","modified_gmt":"2026-09-10T18:18:09","slug":"ce-mark-awarded-to-median-technologies-eyonis-lcs","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/843201\/","title":{"rendered":"CE Mark Awarded to Median Technologies\u2019 eyonis LCS"},"content":{"rendered":"

Median Technologies\u2019<\/a>\u00a0eyonis\u00a0LCS has received CE Mark authorization as a Class IIb medical device under the European Medical Device Regulation (MDR 2017\/745).\u00a0<\/p>\n

The regulatory approval marks a major achievement for eyonis\u00a0LCS, the company\u2019s AI\/ML-powered Software as a Medical Device (SaMD), executives claim. eyonis\u00a0LCS helps clinicians detect lung parenchymal nodules on LDCT scans and characterize them as probably benign, suspicious, or very suspicious, thus supporting early cancer diagnosis, patient risk stratification, improved clinical management, and ultimately enabling lung cancer screening program implementation at scale.<\/p>\n

Following\u00a0the eyonis LCS\u2019s U.S. Food and Drug Administration (FDA) clearance<\/a> in February, the CE marking further expands access to Median\u2019s AI-based SaMD, which is designed to address the biggest clinical unmet needs in lung cancer screening\u2014the false positives and false negatives that significantly hamper existing screening programs.<\/p>\n

EU Lung Cancer Screening Programs <\/p>\n

In the European Union, an estimated 25 to 30 million individuals1 may be eligible for lung cancer screening under current high\u2011risk criteria, representing a substantial and largely untapped addressable market for early diagnostic solutions.<\/p>\n

Lung cancer screening programs across Europe are gaining momentum. While only a limited number of countries have established national programs\u2014such as England, Poland, and Croatia\u2014Europe is entering an acceleration phase, as evidenced by the launch of Germany\u2019s nationwide screening program in April.\u00a0<\/p>\n

At the same time, major countries, including France, are advancing large-scale pilot initiatives that assess the feasibility of organized lung cancer screening in real-world settings. In France, the national IMPULSION study has been launched as a large-scale pilot program to evaluate the feasibility of implementing organized lung cancer screening using low-dose computed tomography in a real-world setting, targeting approximately 20,000 high-risk individuals and combining screening with smoking cessation support.<\/p>\n

Italy also stands out as one of the most advanced European countries in lung cancer screening, with a nationwide network-based approach (RISP) and multiple large-scale pilot programs already underway, providing a real-world foundation for the future expansion of organized screening.<\/p>\n

The key growth drivers for EU lung cancer screening are the transition from pilot programs to national deployment, increasing pressure on radiology capacity, and the progressive integration of standardized, artificial intelligence (AI)-enabled workflows, which will create a strong foundation for scalable, technology-driven solutions such as eyonis LCS.<\/p>\n

\u201cReceiving 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,\u201d Median Technologies Founder\/CEO\u00a0Fredrik Brag said. \u201cSeveral European nations have already launched lung cancer screening programs, 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.\u00a0The CE marking of eyonis LCS\u2014which follows the recent FDA 510(k) clearance for the US market\u2014positions us as a key player in Europe, well\u2011suited to support healthcare systems in scaling screening programs with enhanced accuracy, efficiency, and clinical confidence.\u201d\u00a0<\/p>\n

Ability to Find Lung Cancer Early is Critical<\/p>\n

Lung cancer is the leading cause of cancer death in the EU, accounting for 20% of the total number of cancer deaths.2 Early detection dramatically changes the prognosis of lung cancer. Data from the International Early Lung Cancer Action Program (I-ELCAP) show a 20-year survival rate of 81% for lung cancers diagnosed through annual CT screening and 92% for Stage I cancers resected within two months of diagnosis,3 compared with an estimated five-year survival rate of only 10% to 12% for metastatic lung cancer.4 <\/p>\n

Unlike existing AI-based solutions primarily focused on either lung nodule detection or lung cancer diagnosis outside of screening pathways, eyonis LCS is the world\u2019s first to combine computer\u2011aided detection (CADe) and computer\u2011aided diagnosis (CADx) embedded directly within the diagnostic care pathway of LDCT lung cancer screening.\u00a0<\/p>\n

By enabling the characterization of pulmonary parenchymal nodules during screening, Median\u2019s SaMD can potentially reduce unnecessary downstream workups while supporting earlier and more confident cancer identification by clinicians.<\/p>\n

As more European countries implement national lung cancer screening programs, eyonis LCS\u2019s CE Mark authorization positions Median as a key player in Europe, well\u2011suited to support healthcare systems in scaling screening programs with enhanced accuracy, efficiency, and clinical confidence, according to the company.<\/p>\n

eyonis\u00a0LCS\u2019 manufacturer values have demonstrated a 93.3% sensitivity (finding cancer when present) and 92.4% specificity (ruling out cancer when not present). By contrast, traditional lung cancer screening by unaided radiologists demonstrated 80.3% sensitivity and 76.4% specificity,5 positioning eyonis\u00a0LCS\u2019 performance at a significant clinical advantage.<\/p>\n

eyonis LCS has demonstrated a 68% reduction of False Positives (FP),6 helping clinicians focus on the actual nodules of interest and prevent avoidable follow-up procedures, including potentially harmful invasive ones, reducing overwhelming patient anxiety, and lowering excessive workload for clinical teams amid ongoing workforce shortages.<\/p>\n

eyonis\u00a0LCS has demonstrated a 66% reduction of False Negatives (FN),7 avoiding missed cancers, upgrading patient management, and saving lives.<\/p>\n

Pioneering Software as a Medical Device (SaMD) and imaging services, Median Technologies harnesses cutting-edge AI to enhance early cancer diagnosis and treatment accuracy. Median\u2019s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis, an AI\/ML tech-based suite of SaMD. Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies.\u00a0The French-based company, with a presence in the United States and China, trades on the Euronext Growth market. Median is also eligible for the French SME equity savings plan scheme.<\/p>\n

References
1 Estimate derived from country\u2011level modelling extrapolated to the EU population, and consistent with published epidemiological data on smoking prevalence and high\u2011risk screening criteria.
2\u00a0European Commission Joint Research Center \u2013\u00a02024 estimates of cancer cases and death in the EU, February 2026<\/a>
3\u00a0Henschke CI, Yip R, et al.\u00a0A 20-Year Follow-Up of Participants with Lung Cancer Diagnosed in the International Early Lung Cancer Action Program (I-ELCAP). Radiology. 2023 and International Early Lung Cancer Action Program (I-ELCAP). Research Summary.
4\u00a0American Cancer Society\/SEER survival statistics
5\u00a0Jonas DE, et al. Screening for Lung Cancer with Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Task Force. JAMA. 2021 Mar 9;925(10):971-987
6\u00a0Estimated from Jonas DE, et al. Screening for Lung Cancer with Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Task Force. JAMA. 2021 Mar 9;925(10):971-987
7\u00a0Estimated from Jonas DE, et al. Screening for Lung Cancer with Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Task Force. JAMA. 2021 Mar 9;925(10):971-987<\/p>\n","protected":false},"excerpt":{"rendered":"Median Technologies\u2019\u00a0eyonis\u00a0LCS has received CE Mark authorization as a Class IIb medical device under the European Medical Device…\n","protected":false},"author":2,"featured_media":843202,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[357020,4,450,59984,357021,357022,37523,357023,357024,357025,357026,451,357027,357028,39942,357029,357030,138364,3,48845,5332,357031,268261,357032,357033,357034,357035,452,453],"class_list":["post-843201","post","type-post","status-publish","format-standard","has-post-thumbnail","category-breaking-news","tag-benign","tag-breaking-news","tag-breakingnews","tag-cancer-diagnosis","tag-ce-mark","tag-class-iib","tag-croatia","tag-european-medical-device-regulation","tag-eyonis-lcs","tag-false-negatives","tag-false-positives","tag-headlines","tag-icro","tag-impulsion","tag-lung-cancer","tag-lung-parenchymal-nodules","tag-median-technologies","tag-medical-device","tag-news","tag-oncology","tag-poland","tag-pulmonary","tag-radiologists","tag-samd","tag-software-as-a-medical-device","tag-stratification","tag-suspicious","tag-top-stories","tag-topstories"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/843201","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=843201"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/843201\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/843202"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=843201"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=843201"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=843201"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}