What You Should Know
- Seattle-based RevealDx has secured a $3.4M strategic investment and a global distribution agreement with Melbourne-listed 4DMedical.
- The agreement appoints 4DMedical as the distributor for RevealDx’s flagship software, RevealAI-Lung, across the United States, Europe, Australia, and New Zealand.
- RevealAI-Lung is an AI CADx software that generates a Malignancy Similarity Index (mSI™) to characterize incidental lung nodules, validated on over 1,500 patients.
- The tool has achieved full regulatory triad clearance (US FDA clearance, European MDR certification, and Australian TGA approval) and is reimbursable by U.S. Medicare under CPT codes 0721T and 0722T.
- The move follows 4DMedical’s acquisition of Austrian chest CT company contextflow, into whose platform RevealAI-Lung has already been integrated and deployed at several European clinical sites.
Bypassing Fragmented Radiology Workflows: RevealAI-Lung Integrates into PACS and contextflow
4DMedical has made a $3.4M strategic investment in RevealDx, securing exclusive global distribution rights for its RevealAI-Lung software to build out an integrated, PACS-native cardiopulmonary imaging platform. Chestnut Partners, Inc. served as the exclusive financial advisor to RevealDx for the transaction.
The partnership targets a persistent bottleneck in enterprise radiology: managing incidental lung nodules detected on chest CT scans. While incidental findings are common, accurately characterizing malignancy risk without generating excessive false positives or disrupting radiologist productivity remains a primary operational hurdle for health systems.
RevealDx’s software, RevealAI-Lung, addresses this challenge by generating a Malignancy Similarity Index (mSI™) based on real-world reference data from the National Lung Screening Trial. The algorithm stratifies risk across more than 1,500 patient cohorts to help radiologists distinguish benign nodules from early-stage lung cancers. The software holds FDA clearance, European MDR certification, and Australian TGA approval, and is backed by existing U.S. Medicare coverage under CPT codes 0721T and 0722T.
Under the global distribution agreement, 4DMedical will embed RevealAI-Lung directly into its newly acquired contextflow chest CT platform and pair it with its proprietary CT:VQ™ ventilation-perfusion functional imaging software. By integrating anatomical nodule detection, AI risk scoring, and functional lung physiology into a single PACS interface, the combined stack allows health systems to automate risk stratification without forcing clinicians to navigate standalone software applications.
Andreas Fouras, Founder and CEO of 4DMedical, emphasized the focus on platform integration: “For 4DMedical, this is about more than adding products. It is about building a connected ecosystem for cardiopulmonary care. CT:VQ™ gives physicians physiological insight into how the lung is actually functioning. 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.”
