Median Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for eyonis LCS, its artificial intelligence/machine learning (AI/ML)-powered computer-aided detection and diagnosis (CADe/CADx) Software as a Medical Device intended for lung cancer screening.

Lung cancer is the leading cause of U.S. cancer deaths, and patient outcomes are substantially improved when cancer is identified at early stages. Curable stage 1 lung cancer can be diagnosed through Low-Dose CT (LDCT) screening, yielding roughly an 80% long-term survival versus a 15% five-year survival in symptom-detected disease.

“This FDA 510(k) clearance for eyonis LCS is a major milestone for Median Technologies and an important step toward expanding access to AI-assisted lung cancer screening in the United States. eyonis LCS is the first end-to-end detection and diagnosis device FDA-cleared, specifically targeting lung cancer screenings,” Median Technologies Founder/CEO Fredrik Brag stated. “We believe eyonis LCS will prove to be a game changer for clinical teams as they manage rising screening volumes and help healthcare systems deliver high-accuracy and timely lung cancer diagnosis for eligible patients. We are now fully positioned to execute our go-to-market strategy and deploy eyonis LCS at scale to potentially help save hundreds of thousands of lives in the U.S. alone in the coming years.” 

By supporting detection and characterization of parenchymal pulmonary nodules on LDCT scans, eyonis LCS is designed to help clinicians identify suspicious findings earlier, reduce inter-reader variability and improve lung cancer screening program efficiency and consistency.

eyonis Lung Cancer Screening (LCS) is designed to analyze imaging data generated from LDCT scans and assist radiologists in detecting and characterizing parenchymal pulmonary nodules, supporting clinical decision-making and patient follow-ups. By identifying suspicious lesions earlier, eyonis LCS supports diagnosis at stages where patient outcomes can be significantly improved.

In manufacturer performance testing on a lung cancer screening reference population, eyonis LCS demonstrated 93.3% sensitivity, 92.4% specificity, and a 99.9% Negative Predictive Value (NPV). The high Negative Predictive Value (NPV) of eyonis LCS demonstrates a very low level in false positives (one per 1,000), which provides clinicians with a high diagnostic confidence level, thereby enabling them to identify individuals who can remain in standard screening pathways versus those requiring recall, avoiding unnecessary follow-up procedures.

“Lung cancer screening combined with eyonis LCS has the capacity to deliver one of the most impactful advances in cancer care by identifying cancer at a stage where it can be cured. eyonis LCS will empower U.S. clinicians to significantly transform lung cancer patient outcomes,” Brag stated. “We will now continue leveraging our AI expertise to expand into additional cancer indications—including Incidental Pulmonary Nodules, HCC (liver cancer), pancreatic, colon and prostate cancer, always with the same objective—finding cancer at a stage where it can be cured.” 

In addition to performance, eyonis LCS is engineered to integrate seamlessly into existing healthcare workflows, enhancing diagnosis accuracy, and reducing routine workload. eyonis LCS can be directly integrated into hospital Picture Archiving and Communication Systems (PACS).

Approximately 14.5 million U.S. residents are currently eligible for lung cancer screening, and eyonis LCS benefits from an established reimbursement framework, creating a favorable environment for rapid scale.

The USPSTF eligible population for U.S. lung cancer screening using LDCT includes adults aged 50 to 80 years with a 20-pack-year smoking history. Based on current eligibility criteria, 14.5 million individuals qualify for screening, and this population is expected to increase over time as screening guidelines expand.

Median Technologies believes that eyonis LCS can play a major role in helping healthcare systems expand access to screening, reduce operational burden, and support more standardized parenchymal nodule evaluation, particularly as screening volumes grow amid a worsening shortage of radiologists.

Median plans to commercialize eyonis LCS in the United States through a combination of direct enterprise sales, strategic distribution partnerships, and integration into existing clinical environments. Median will utilize the current CMS reimbursement framework, including applicable New Technology APC pathways, while working toward broader, long-term insurance coverage.

Alongside its U.S. rollout, the company continues to advance the European regulatory pathway and expects CE marking in Q2 2026, expanding access to this technology to hundreds of thousands of European patients.

Providing software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance early cancer diagnosis and treatment accuracy. Median’s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis, an AI/ML tech-based suite of software as a medical device (SaMD). The 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 (PEA-PME).