First AI Software for Integrated Detection and Diagnosis
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 approval marks a significant advance in integrating artificial intelligence into population-level cancer screening.
What sets eyonis LCS apart is its integrated approach: while most AI software focuses on 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.
Validated Clinical Performance
Approval was based on the RELIVE pivotal 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.
- Sensitivity: 93.3% — detects the vast majority of cancers
- Specificity: 92.4% — low false positive rate
- Negative Predictive Value: 99.9% — only 1 false positive per 1,000 exams
Reimbursement and Commercialization
Eyonis LCS is already reimbursable under Medicare at $601-$700 per exam via CPT codes 0721T and 0722T. The company plans U.S. distribution through a Tempus partnership and expects European CE marking in Q2 2026.
For professionals working with radiology coding and billing, the existence of specific CPT codes and defined reimbursement facilitates clinical adoption. Integration with existing DICOM systems enables workflow incorporation without major infrastructure changes.
Impact on Lung Screening
Lung cancer remains the deadliest cancer worldwide. Low-dose CT screening programs reduce mortality but face challenges with inter-reader variability and high exam volumes. AI tools like eyonis LCS can standardize reading quality and increase diagnostic confidence.
Source: AuntMinnie and Diagnostic Imaging