The tool is designed to help radiologists evaluate pulmonary nodules and recommend follow-up care.
RevealDx announced it has received EU MDR Certification of RevealAI-Lung, which characterizes nodules by producing a score called the Malignancy Similarity Index (mSI) to assist radiologists with the creation of follow-up recommendations.
The company reports validating the software on over 1,500 patients from a variety of cohorts. RevealAI-Lung is designed to reduce time to diagnosis and minimize false positives in lung nodules characterization.
“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,” says Chris Wood, CEO of RevealDx, in a release. “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.
The software can be purchased from RevealDx or through the company’s exclusive EU distributor, contextflow. The company previously announced it has integrated with Riverain, a US nodule detection company, and partnered with Sirona, the provider of cloud-native PACS.
This device is not cleared by the US Food and Drug Administration and is intended for use in markets with EU MDR compliance.
Photo caption: RevealAI-Lung
Photo credit: RevealDx
