CT:VQ™ Redefines Lung Imaging: FDA Clearance Makes Non-Contrast V/Q Scans a Reality

12 September 2025
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In a landmark move for pulmonary diagnostics, 4DMedical’s CT:VQ™ earned FDA 510(k) clearance in September 2025, marking it as the first and only non-contrast ventilation–perfusion (V/Q) imaging solution. The technology is available via routine chest CT scans. With CMS confirming reimbursement under Category III CPT codes (on top of the existing chest CT payment), CT:VQ™ is poised to redefine accessibility and efficiency in functional lung imaging.

What’s So Game-Changing About CT:VQ™?

Workflow Simplification
Patients breeze through a single CT appointment, and radiologists receive quantitative ventilation (V) and perfusion (Q) maps directly in their PACS environment. 

Seamless Integration
Delivered as a cloud-based Software-as-a-Service (SaaS), CT:VQ™ seamlessly integrates into existing radiology workflows (DICOM/PACS) and complements the 14,500+ CT scanners already installed across the U.S. 

Leveling the Playing Field
Hospitals and imaging centers, especially those without nuclear medicine capabilities, can now perform V/Q imaging, bringing advanced diagnostics to community and rural settings nationwide.

Why Clinicians Are Eyeing This as a Breakthrough

As CEO Andreas Fouras, PhD, stated: “CT:VQ™ gives clinicians all the contrast—and none of the injections… the word ‘breakthrough’ is overused, but we believe the unprecedented capabilities of CT:VQ™ qualify for that description.” CT:VQ™ is not just a diagnostic tool—it’s poised to displace 100% of nuclear V/Q scans over time, while also opening new applications in disease monitoring and population health screening. Clinical partners already include top institutions like Stanford University and Brooke Army Medical Center.

Key clinical applications include pulmonary embolism workups, Chronic Thromboembolic Pulmonary Hypertension (CTEPH) assessments, COPD phenotyping, Bronchoscopic Lung Volume Reduction (BLVR) planning, and tracking disease progression and response to treatment. CT:VQ™ underwent rigorous validation, from head-to-head testing against SPECT to expert reader evaluations and real-world clinical cases. It demonstrated equivalent diagnostic accuracy with clearer and fewer artifacts. 

The benefits across healthcare are numerous, as patients can receive faster and safer lung imaging while radiologists benefit from high-resolution functional maps. Because CT:VQ™ can be layered on top of current hospital infrastructure, busy radiologists benefit from streamlined workflows, and clinics and hospitals can gain new capabilities without investing in nuclear medicine equipment. Healthcare systems can achieve cost-efficient uptake with Medicare reimbursement, requiring minimal infrastructure.

CT:VQ™ is ready for prime time—embracing a future of accessible, high-resolution, non-invasive lung function imaging.

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