4DMedical has secured a pivotal three-year contract with SimonMed Imaging to deploy its CT:VQ™ lung imaging technology across over 170 US outpatient centres, while FY26 revenue rose 23% to $7.2 million on record scan volumes and global expansion.
- Three-year commercial agreement with SimonMed Imaging
- FY26 revenue up 23% to $7.2 million with 43% scan volume growth
- CT:VQ™ clinical validation boosts lung surgery outcomes
- Acquisition of European AI firm contextflow completed
- TGA approval enables Australian commercial rollout
US Market Breakthrough with SimonMed Imaging
4DMedical (ASX:4DX) has taken a major step in commercialising its CT:VQ™ lung imaging technology in the US by signing a three-year agreement with SimonMed Imaging. This deal grants immediate clinical deployment across SimonMed’s network of more than 170 outpatient imaging centres spanning 10 states, bypassing the usual evaluation phase entirely. The arrangement, based on per-scan pricing, signals strong confidence in CT:VQ™’s clinical and operational value and sets the stage for a significant volume ramp in a high-throughput community setting.
SimonMed will also collaborate on developing reimbursement evidence by sharing insurance claims data, a critical move towards broader payor acceptance. This partnership extends 4DMedical’s reach beyond leading Academic Medical Centres (AMCs) into scaled outpatient networks, reflecting a strategic progression from early adopters to mainstream adoption.
Clinical Validation Enhances Market Appeal
Meanwhile, the launch of the CLEAR clinical program aims to fast-track CT:VQ™ into the acute pulmonary embolism (PE) market, a US$3 billion opportunity. CLEAR’s multi-centre study, anchored at Massachusetts General Hospital, compares CT:VQ™ directly with the current CT pulmonary angiography standard, potentially enabling contrast-free functional lung imaging for millions of PE patients annually.
European Expansion and Strategic Partnerships
Post quarter, 4DMedical completed the acquisition of Austrian AI lung imaging company contextflow, establishing a European commercial, regulatory, and product development platform. The deal, valued at approximately A$18.56 million upfront plus contingent options, adds lung cancer screening and incidental findings technologies to 4DMedical’s portfolio, enhancing its global lung health leadership.
Simultaneously, strategic investments in RevealDx and a partnership with Azra AI broaden the company’s capabilities in AI-driven malignancy risk assessment and patient navigation. RevealDx’s FDA-cleared RevealAI-Lung product integrates with hospital workflows to help identify high-risk lung nodules, while Azra AI’s oncology platform supports timely patient follow-up and care coordination, creating a seamless clinical pathway from detection to treatment.
Regulatory Milestones and Australian Commercial Rollout
4DMedical secured Therapeutic Goods Administration (TGA) approval for CT:VQ™ in June 2026, enabling commercial deployment across Australia. Multiple paid contracts have been executed, and patient scanning is underway, marking a swift transition from regulatory clearance to market launch. The company is preparing a submission to the Medical Services Advisory Committee for Medicare reimbursement, aiming to establish CT:VQ™ as a standard reimbursable service.
Additional regulatory achievements include UKCA certification and Health Canada clearance for related imaging solutions, supporting a broad international commercial footprint.
Financial Strength Supports Growth Strategy
For FY26, 4DMedical reported operating revenue of $7.2 million, a 23% increase on the prior year, driven by higher paid scan volumes and sustained margins above 90%. The installed base grew 39% year-on-year to 540 sites globally, excluding SimonMed’s network, while quarterly scan volumes hit a record 105,970, up 43% versus the prior corresponding period.
Despite investing in growth initiatives, the company maintained a robust cash position of $278 million at 30 June 2026. Net operating cash outflows rose modestly to $9.4 million in Q4, reflecting strategic scaling efforts.
US Legislative Support for 4D Lung Imaging
A bipartisan bill introduced in the US House of Representatives, the AIRCARE for Vets Act, proposes a US$20 million pilot program within the Department of Veterans Affairs to adopt 4D functional lung imaging technology. This legislative development underscores growing recognition of advanced respiratory imaging’s role in veteran healthcare and could accelerate adoption within a key US market segment.
Bottom Line?
4DMedical’s successful US commercial launch and expanding global footprint, backed by strong clinical validation and regulatory progress, position it for accelerated revenue growth; though execution of reimbursement pathways and integration of recent acquisitions will be critical to sustaining momentum.
Questions in the middle?
- How quickly will Medicare reimbursement approval in Australia follow TGA clearance, and what impact will it have on adoption?
- Can 4DMedical leverage the SimonMed partnership to secure similar deals with other large US outpatient networks?
- Will the CLEAR clinical program validate CT:VQ™ as a viable alternative to CT pulmonary angiography in acute pulmonary embolism?