Admin_Adham
An artificial intelligence (AI)-powered tool that characterizes lung nodules has earned clearance from the FDA, according to a press release from manufacturer RevealDx.
The RevealAI-Lung software incorporates AI and radiomics to help radiologists characterize lung nodules on imaging more quickly and with fewer false positives, according to the company. The tool analyzes nodule images and generates a malignancy score called the Malignancy Similarity Index to assess risk and identify malignant nodules, which may promote earlier intervention and reduce unnecessary procedures.
The RevealAI-Lung CADx was validated in more than 1500 patients from a range of populations, according to the press release, and it is designed to integrate with the Picture Archiving and Communication System to improve workflow.
Although data are limited, a recent retrospective study in the UK of 100 control individuals and 100 cancer patients with confirmed diagnoses showed that RevealAI-Lung would have upgraded 44% of the patients with cancer, thereby significantly reducing delayed cancer diagnoses from 45% to 25%, according to the researchers.
The clearance allows for Medicare reimbursement via codes 0721T and 0722T and follows the company’s MDR certification from the EU for the technology in November 2025.
