FDA Issues 510(k) Clearance for AI-Powered Lung Cancer Detection on Low-Dose CT Scans

The Food and Drug Administration (FDA) has granted 510(k) clearance for the AI-enabled eyonis® LCS software, which may facilitate earlier detection of lung cancer on low-dose computed tomography (CT) scans.

Noting the eligibility of approximately 14.5 million people in the United States for lung cancer screening, Median Technologies, the developer of the eyonis LCS software, said the technology is geared toward earlier detection and characterization of parenchymal pulmonary nodules.

Citing internal performance testing of the software in a lung screening reference cohort, Median Technologies noted the eyonis LCS software has demonstrated a 93.3 percent sensitivity rate, a 92.4 percent specificity rate and a 99.9 percent negative predictive value (NPV).

“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,” noted Fredrik Brag, the CEO and founder of Median Technologies.

Use of the eyonis LCS software is eligible for reimbursement via the category III CPT codes 0721T and 0722T with a range of $601-$700 for Medicare payments, according to Median Technologies.