FDA Clearance of CT:VQ™ Challenges Nuclear Lung Scans, But Adoption Risks Remain

A New Era in Lung Imaging

4DMedical Limited (ASX – 4DX) has reached a pivotal milestone with the U.S. Food and Drug Administration granting 510(k) clearance for its CT – VQ™ technology. This innovation marks the first time ventilation-perfusion imaging, a critical diagnostic tool for lung conditions, can be performed without the need for radioactive tracers or contrast agents, using standard CT scans instead.

Traditionally, ventilation-perfusion (VQ) scans rely on nuclear medicine techniques involving inhaled and injected radiotracers, which require specialized equipment and lengthy procedures. CT – VQ™ sidesteps these challenges by extracting detailed functional lung data from routine CT imaging, offering a safer, faster, and more accessible alternative.

Clinical Validation and Market Potential

The FDA clearance was supported by a robust clinical validation package demonstrating CT – VQ™’s diagnostic accuracy matches that of the current gold standard, SPECT nuclear imaging. Independent radiologists and lung specialists confirmed the technology’s ability to identify lung ventilation and perfusion abnormalities across multiple conditions, including pulmonary embolism, COPD, and asthma.

With over one million nuclear VQ scans performed annually in the U.S. alone, reimbursed at roughly USD 1,150 each, the immediate addressable market exceeds USD 1.1 billion. 4DMedical anticipates rapid adoption, leveraging the existing infrastructure of approximately 14,500 CT scanners nationwide, including in rural and smaller healthcare facilities that lack nuclear medicine capabilities.

Broader Implications and Commercial Outlook

Beyond replacing nuclear VQ scans, CT – VQ™ holds promise to expand the use of ventilation-perfusion imaging into new clinical areas such as disease monitoring, treatment planning, and population health screening. Early commercial contracts with prestigious institutions like Stanford University and Brooke Army Medical Center underscore growing interest and confidence in the technology.

4DMedical’s CEO Andreas Fouras highlighted the transformative potential of CT – VQ™, emphasizing its compatibility with existing CT infrastructure and its ability to redefine pulmonary imaging standards. The company plans to accelerate commercial rollout across the U.S., engaging healthcare providers and strategic partners to integrate CT – VQ™ into routine clinical practice.

This FDA clearance not only validates 4DMedical’s technological breakthrough but also positions the company at the forefront of a significant shift in respiratory diagnostics, potentially reshaping patient care and clinical workflows.