FDA Clears AI-Powered Software for Assessment of Incidental Lung Nodules on CT

The Food and Drug Administration (FDA) has issued 510(k) clearance for the RevealAI-Lung software for the assessment of incidental lung nodules detected on CT.

Validated on over 1,500 patients from a variety of cohorts, the RevealAI-Lung software enables one to click on a nodule and obtain a Malignancy Similarity Index (mSI™). Through proprietary analytics, the mSI score provides clinical insights that may facilitate earlier detection and reduce unnecessary procedures, according to RevealDx, the manufacturer of the software.

“We are most excited about the anticipated positive impact on patient care that will result from the use of RevealAI-Lung,” noted Chris Wood, the CEO of RevealDx.

Noting that the RevealAI-Lung can be integrated directly into a facility’s given PACS system, RevealDx said use of the RevealAI-Lung software for Medicate recipients is reimbursable with the Medicare codes 0721T and 0722T.