{"id":12765,"date":"2026-02-16T05:22:24","date_gmt":"2026-02-16T08:22:24","guid":{"rendered":"https:\/\/rtmedical.com.br\/median-eyonis-fda-lung-cancer\/"},"modified":"2026-03-12T06:51:03","modified_gmt":"2026-03-12T09:51:03","slug":"median-eyonis-fda-lung-cancer","status":"publish","type":"post","link":"https:\/\/rtmedical.com.br\/en\/median-eyonis-fda-lung-cancer\/","title":{"rendered":"FDA Clears Median AI for Lung Cancer Screening"},"content":{"rendered":"<h2>First AI Software for Integrated Detection and Diagnosis<\/h2>\n<p>Median Technologies has received FDA 510(k) clearance for eyonis LCS, the first AI software combining both detection (CADe) and diagnostic assistance (CADx) for lung cancer screening on low-dose CT scans. The clearance marks a significant advance in integrating artificial intelligence into population-level cancer screening.<\/p>\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" class=\"alignleft lazyload\" data-src=\"https:\/\/rtmedical.com.br\/wp-content\/uploads\/2026\/02\/median-eyonis-fda-cancer-pulmao.jpg\" alt=\"Artificial intelligence software analyzing chest CT scan for pulmonary nodule detection\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 1880px; --smush-placeholder-aspect-ratio: 1880\/1253;\"><figcaption>eyonis LCS analyzes low-dose CT to detect and classify pulmonary nodules<\/figcaption><\/figure>\n<p>What sets eyonis LCS apart is its integrated approach: while most AI software is limited to either detecting nodules or classifying them, this is the first to do both in a single product. The software analyzes low-dose CT to characterize pulmonary nodules and produce a malignancy risk score, assisting the radiologist in clinical decision-making.<\/p>\n<h2>Validated Clinical Performance<\/h2>\n<p>The clearance was based on the RELIVE pivotal clinical trial (NCT06751576), which demonstrated statistically significant improvement (p=0.027) in diagnostic performance when eyonis is used alongside a radiologist, compared to a radiologist alone.<\/p>\n<p>The performance numbers are robust:<\/p>\n<ul>\n<li><strong>Sensitivity:<\/strong> 93.3% \u2014 detects the vast majority of cancers<\/li>\n<li><strong>Specificity:<\/strong> 92.4% \u2014 low false-positive rate<\/li>\n<li><strong>Negative Predictive Value:<\/strong> 99.9% \u2014 when the result is negative, the confidence that there is truly no cancer is extremely high (only 1 false positive per 1,000 exams)<\/li>\n<\/ul>\n<h2>Reimbursement and Commercialization<\/h2>\n<p>An important practical aspect: eyonis LCS is already reimbursable under Medicare, at values between $601 and $700 per exam, through CPT category III codes 0721T and 0722T. The company plans U.S. distribution through a partnership with Tempus and expects to obtain European CE marking in the second quarter of 2026.<\/p>\n<p>For professionals working with <a href=\"https:\/\/rtmedical.com.br\/?p=12553\">radiology coding and billing<\/a>, the existence of a specific CPT code and defined reimbursement value significantly facilitates clinical adoption. Integration with <a href=\"https:\/\/rtmedical.com.br\/?p=12596\">existing DICOM systems<\/a> enables workflow incorporation without major infrastructure changes.<\/p>\n<h2>Impact on Lung Screening<\/h2>\n<p>Lung cancer remains the deadliest cancer worldwide. Low-dose CT screening programs have demonstrated mortality reduction but face challenges with inter-reader variability and high exam volumes. AI tools like eyonis LCS can standardize reading quality and increase diagnostic confidence.<\/p>\n<p><strong>Source:<\/strong> <a href=\"https:\/\/www.auntminnie.com\/imaging-informatics\/artificial-intelligence\/article\/15817030\/median-secures-us-fda-clearance-for-eyonis-lung-cancer-screening-software\" target=\"_blank\" rel=\"noopener\">AuntMinnie<\/a> and <a href=\"https:\/\/www.diagnosticimaging.com\/view\/fda-510-k-clearance-ai-powered-lung-cancer-detection-low-dose-ct-scans\" target=\"_blank\" rel=\"noopener\">Diagnostic Imaging<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Median Technologies receives FDA clearance for eyonis LCS, first AI combining detection and diagnosis for lung cancer screening.<\/p>\n","protected":false},"author":1,"featured_media":12761,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"ngg_post_thumbnail":0,"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[102,100],"tags":[],"class_list":{"0":"post-12765","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-ai","8":"category-radiology"},"aioseo_notices":[],"rt_seo":{"title":"","description":"","canonical":"","og_image":"","robots":"default","schema_type":"default","include_in_llms":false,"llms_label":"","llms_summary":"","faq_items":[],"video":[],"gtin":"","mpn":"","brand":"","aggregate_rating":[]},"_links":{"self":[{"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/posts\/12765\/"}],"collection":[{"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/posts\/"}],"about":[{"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/types\/post\/"}],"author":[{"embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/users\/1\/"}],"replies":[{"embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/comments\/?post=12765"}],"version-history":[{"count":0,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/posts\/12765\/revisions\/"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/media\/12761\/"}],"wp:attachment":[{"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/media\/?parent=12765"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/categories\/?post=12765"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/tags\/?post=12765"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}