RevealDx has entered a distribution agreement with 4DMedical, which is also making a $3.4 million strategic investment in the company, that will expand access to RevealDx's RevealAI-Lung software.
Under the agreement, 4DMedical will distribute RevealAI-Lung in the U.S., Europe, Australia, and New Zealand. RevealAI-Lung characterizes incidental lung nodules on CT scans using a so-called Malignancy Similarity Index, a score intended to help radiologists make follow-up recommendations for potential cancer diagnoses, according to the company. RevealDx said it has validated the software on more than 1,500 patients across a variety of cohorts.
The software has received CE marking under the EU Medical Device Regulation (MDR), approval from Australia's Therapeutic Goods Administration (TGA), and clearance from the U.S. Food and Drug Administration (FDA), and is reimbursable by Medicare under CPT codes 0721T and 0722T, the company said.
