4DMedical’s CT:VQ Shows Strong Clinical Validation Ahead of FDA Submission
4DMedical has submitted its CT:VQ lung imaging technology for FDA clearance, aiming to disrupt the $1 billion US nuclear lung scan market with a non-nuclear, lower-cost alternative. Clinical studies show CT:VQ matches or exceeds existing nuclear imaging in accuracy and patient experience.
- CT:VQ submitted for FDA 510(k) clearance
- Clinical validation shows equivalence or superiority to nuclear SPECT VQ scans
- Targets $1 billion US nuclear lung scan market with non-nuclear alternative
- Partnership with Philips and CMS reimbursement support commercialization
- Operational cost reductions and expanded sales force in place
A New Era in Lung Imaging
4DMedical Limited (ASX:4DX) has unveiled a significant milestone in lung imaging technology with the submission of its CT:VQ system for FDA 510(k) clearance. This innovative software overlays functional ventilation and perfusion analysis onto standard non-contrast CT scans, offering a non-nuclear alternative to traditional ventilation-perfusion (VQ) scans that rely on radioactive tracers.
Conventional nuclear medicine VQ scans, including SPECT and planar scintigraphy, are costly, logistically complex, and often limited by low resolution and patient throughput constraints. CT:VQ promises to overcome these hurdles by leveraging existing CT infrastructure, eliminating the need for radiopharmaceuticals, and delivering higher-resolution images with fewer artifacts.
Clinical Validation and Market Potential
Multi-center clinical evaluations have demonstrated that CT:VQ matches or surpasses the diagnostic accuracy of nuclear SPECT VQ scans. Quantitative assessments revealed strong correlations (r>0.8) between CT:VQ and SPECT measurements of lung ventilation and perfusion. In addition, CT:VQ showed a higher correlation with physiological lung function tests, such as diffusion capacity for carbon monoxide (DLCO), suggesting superior signal quality and clinical relevance.
Reader studies involving expert radiologists confirmed excellent agreement between CT:VQ and SPECT images across all lung zones, with CT:VQ providing clearer images free from common nuclear imaging artifacts. These findings underpin 4DMedical’s confidence in CT:VQ’s potential to rapidly displace the existing $1 billion US nuclear VQ scan market, which currently performs around one million scans annually.
Commercial and Regulatory Momentum
4DMedical has secured extensive regulatory clearances across multiple regions and has obtained Centers for Medicare & Medicaid Services (CMS) reimbursement codes supporting CT:VQ adoption. A strategic commercial partnership with Philips further expands the company’s sales coverage and market reach within the US healthcare system.
Operationally, 4DMedical has implemented cost controls reducing annual operating expenses by over $6.5 million and expanded its sales force by more than 25 times to capitalize on the growing opportunity. Feedback from leading clinicians, including Professor D. Kyle Hogarth of the University of Chicago, highlights strong enthusiasm for CT:VQ’s ability to streamline workflows, improve patient care, and reduce diagnostic delays.
Looking Ahead
Pending FDA clearance, CT:VQ is poised to transform lung function imaging by offering a safer, faster, and more accessible diagnostic tool. By integrating seamlessly into existing CT workflows and eliminating the need for radioactive materials, CT:VQ could redefine standards of care for millions of patients with respiratory conditions worldwide.
Bottom Line?
With FDA review underway, 4DMedical’s CT:VQ could soon reshape lung imaging economics and patient care in the US and beyond.
Questions in the middle?
- When will the FDA complete its review and grant clearance for CT:VQ?
- How quickly can 4DMedical scale commercial adoption to capture the $1 billion US nuclear VQ market?
- What competitive responses might emerge from established nuclear imaging providers?