The SaMD combines detection and characterization capabilities in low-dose CT scans with 93.3% sensitivity and 92.4% specificity.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Median Technologies for eyonis LCS, an artificial intelligence (AI)-powered device capable of both detecting and diagnosing lung cancer in screening programs.
The software as a medical device analyzes low-dose CT scans to help radiologists identify and characterize pulmonary nodules, supporting clinical decision-making for the 14.5 million Americans eligible for lung cancer screening. In manufacturer performance testing, eyonis LCS demonstrated 93.3% sensitivity, 92.4% specificity, and 99.9% negative predictive value.
“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,” says Fredrik Brag, CEO and founder of Median Technologies, in a release. “eyonis LCS is the first end-to-end detection and diagnosis device FDA cleared, specifically targeting lung cancer screenings.”
Addressing Radiologist Shortage and Screening Volumes
The device is designed to integrate directly into hospital picture archiving and communication systems, supporting existing workflows as healthcare systems manage rising screening volumes amid a radiologist shortage. The high negative predictive value aims to reduce false positives, with the company reporting one false positive per 1,000 cases.
Current US Preventive Services Task Force guidelines recommend lung cancer screening for adults aged 50 to 80 years with a 20-pack-year smoking history. Lung cancer remains the leading cause of cancer death in the US, with stage 1 disease yielding approximately 80% long-term survival compared to 15% five-year survival when detected after symptoms appear.
Established Reimbursement Pathway
The device benefits from existing reimbursement under Category III CPT codes 0721T and 0722T, both assigned to New Technology APC 1508, with Medicare payments ranging from $601 to $700. This established framework is expected to accelerate adoption among imaging providers.
Median Technologies plans to commercialize eyonis LCS through direct enterprise sales, strategic distribution partnerships, and integration into existing clinical environments. The Sophia Antipolis, France-based company expects CE marking in the second quarter of 2026 for European market access.
The company is also developing AI applications for additional cancer types, including liver, pancreatic, colon, and prostate cancers, as well as incidental pulmonary nodule detection.
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