4DMedical Files FDA Submission for Game-Changing CT Lung Imaging Software

A New Era in Lung Imaging

4DMedical Limited, an innovator in respiratory imaging technology, has taken a significant step forward by filing a 510(k) submission with the U.S. Food and Drug Administration (FDA) for its CT:VQ™ software. This product promises to transform how lung ventilation and perfusion are assessed, moving away from traditional nuclear medicine scans that rely on radiotracers and gamma cameras.

Ventilation perfusion (VQ) scans are critical diagnostic tools for detecting pulmonary embolism and other lung conditions by evaluating airflow and blood flow in the lungs. However, conventional nuclear VQ scans are complex, time-consuming, and require specialized equipment and radiotracers, limiting accessibility and scheduling flexibility.

CT:VQ™, Innovation Meets Practicality

CT:VQ™ leverages routine non-contrast CT scans to generate detailed ventilation and perfusion maps without the need for any radiotracers or contrast agents. By measuring regional lung motion and tissue density changes, it provides high-resolution, quantitative data that matches or exceeds the diagnostic quality of SPECT imaging, the current gold standard.

This approach addresses key clinical and logistical challenges: it eliminates radiotracer handling, integrates seamlessly into existing CT workflows, and taps into the vast installed base of approximately 14,500 CT scanners across the U.S., including those in rural and smaller healthcare facilities. This could democratize access to comprehensive lung function assessment, previously limited to specialized nuclear medicine departments.

Market Potential and Clinical Validation

The U.S. market alone performs over one million nuclear VQ scans annually, with reimbursements averaging around USD $1,150 per scan, representing a market exceeding USD $1.1 billion. 4DMedical aims to capture this entire market and expand it by enabling new applications in disease monitoring and screening, thanks to CT:VQ™’s accessibility and ease of use.

Extensive clinical validation supports the submission, including quantitative comparisons showing strong correlation between CT:VQ™ and SPECT, expert reader assessments confirming diagnostic agreement, and case studies highlighting CT:VQ™’s superior image quality and absence of common SPECT artifacts. These findings suggest CT:VQ™ can reliably replicate and potentially improve upon existing nuclear VQ imaging.

Path to Adoption and Reimbursement

4DMedical anticipates that CT:VQ™ will align with its existing CT LVAS™ CPT reimbursement code valued at approximately USD $650, facilitating rapid clinical uptake. The non-contrast CT-based method also offers economic advantages for hospitals operating under fixed payment models, potentially accelerating adoption in inpatient settings.

Early clinical trials and feedback from leading institutions, including Brooke Army Medical Center and University of Chicago Medicine, have been overwhelmingly positive. Clinicians appreciate the ability to obtain comprehensive lung function data from CT scans they are already ordering, enhancing diagnostic insight without disrupting workflow.

Looking Ahead

The FDA’s decision on the 510(k) submission is expected within approximately 120 days, marking a pivotal moment for 4DMedical. If cleared, CT:VQ™ could rapidly disrupt the established nuclear VQ scan market and expand the role of functional lung imaging in respiratory care.