Photo: RevealDx
Nov. 3, 2025 — RevealDx, a leader in the characterization of lung nodules, has introduced MDR Certification of RevealAI-Lung.
The RevealDX product, RevealAI-Lung, characterizes nodules by producing a score called the Malignancy Similarity Index (mSI) to assist radiologists with the creation of follow-up recommendations. The company has validated the software on more than 1,500 patients from a variety of cohorts. RevealAI-Lung is the first device with claims for lung nodules that certifies it reduces time to diagnosis and reduces false positives.
“Our technology is augmentative, not just assistive, uncovering radiomic biomarkers invisible to the human eye. RevealAI-Lung’s mSI score adds significant value to the Radiologist as they determine the best follow up recommendation for the patient,” said Chris Wood, CEO of RevealDx. “The technology has the potential to identify up to 45% of malignant nodules when they first appear, instead of waiting for an interval scan. As part of a comprehensive nodule management program, that could translate to thousands of lives saved each year.”
This announcement comes alongside Lung Cancer Awareness Month, taking place in November to raise public knowledge about the disease and encourage early detection and prevention. As a part of the company’s commitment to advancing lung health, RevealDx will also be exhibiting at the RSNA Meeting in Chicago later this month.
The software can be purchased directly from RevealDx or through the company's exclusive EU distributor, contextflow. The company previously announced it has integrated with Riverain, the leading US nodule detection company, and has partnered with Sirona, the leader in cloud native PACS.
Additional information is available at https://reveal-dx.com/.
Please note: This device is not FDA cleared and is intended for use in markets with EU MDR compliance.
November 17, 2025 
