RevealDx has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RevealAI-Lung software for characterizing nodules.
The software, validated on over 1,500 patients across a range of cohorts, characterizes nodules by producing a Malignancy Similarity Index (mSI) score to help radiologists make informed follow-up recommendations for cancer diagnosis.
The software can be directly integrated into PACS systems, according to RevealDx.
With this clearance, RevealAI-Lung is now reimbursable using codes 0721T and 0722T, with a current Medicare payment rate in OPPS of $650, RevealDx noted.
RevealAI-Lung received EU Medical Device Regulation (MDR) Certification in November 2025.
The software can be purchased directly from the firm or through its U.S. distributor Sirona, the company said.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
