RevealDx has entered into a distribution agreement with 4DMedical and received a $3.4 million strategic investment from the medical technology company to expand access to RevealAI-Lung, its AI-powered lung nodule characterization software.
Under the agreement, 4DMedical will distribute RevealAI-Lung across the United States, Europe, Australia and New Zealand.
RevealAI-Lung has received FDA clearance in the U.S., Medical Device Regulation certification in Europe and Therapeutic Goods Administration approval in Australia.
Chestnut Partners served as exclusive financial advisor to RevealDx on the transaction.
The partnership follows 4DMedical’s recent acquisition of Austria-based contextflow, which develops chest CT technology that automates the identification of lung nodules.
RevealAI-Lung has already been integrated into the contextflow platform and is operating at several clinical sites across Europe.
RevealDx’s technology analyzes incidental lung nodules and generates a Malignancy Similarity Index, or mSI, designed to help radiologists make more informed follow-up recommendations when assessing potentially cancerous nodules.
The company said RevealAI-Lung has been validated across more than 1,500 patients from multiple cohorts.
RevealDx said the software has demonstrated improvements in radiologist reader performance and uses real-world National Lung Screening Trial data as its reference population.
The platform also provides malignancy scoring and integrates directly into picture archiving and communication systems, or PACS, with the goal of minimizing disruption to radiology workflows.
RevealDx said its technology has demonstrated generalizability across different imaging exam types and patient populations.
The companies are positioning the partnership as part of a broader effort to build a connected cardiopulmonary imaging platform combining disease detection, functional imaging and AI-based risk assessment.
4DMedical’s portfolio includes CT:VQ, which provides ventilation and perfusion insights into lung function, along with other respiratory imaging products based on its XV Technology.
By adding RevealAI-Lung, 4DMedical aims to combine functional imaging with tools that identify and assess potentially malignant lung nodules.
RevealAI-Lung is also reimbursable through Medicare in the U.S. under CPT codes 0721T and 0722T, which RevealDx said could support broader clinical adoption.
RevealDx describes RevealAI-Lung as the first medical imaging AI software to achieve reimbursement in both the U.S. and European Union.
The company has also published studies indicating that the technology can improve early cancer detection while reducing false-positive findings.
4DMedical has expanded its AI capabilities through acquisitions including Imbio in 2023 and contextflow in 2026.
KEY QUOTES:
“As we recognize World Lung Cancer Day, this milestone underscores our commitment to helping clinicians identify potentially malignant lung nodules earlier and with greater confidence. The incredible team at 4DMedical and the resources they bring will expand our reach and benefit patients.”
Chris Wood, CEO of RevealDx
“For 4DMedical, this is about more than adding products. It is about building a connected ecosystem for cardiopulmonary care.”
“By surrounding that capability with disease detection, and AI-powered risk stratification, we can help health systems identify the right patients earlier and ensure they receive appropriate care.”
Andreas Fouras, Founder and CEO of 4DMedical
