#USA #Los Angeles #FDA Clearance #4DMedical #CT:VQ™

4DMedical’s Revolutionary CT:VQ™ Receives FDA 510(k) Clearance

4DMedical, a pioneering company in advanced respiratory imaging, has announced a monumental step forward with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its innovative solution, CT:VQ™. This product is recognized as the first and only non-contrast ventilation-perfusion (VQ) imaging technology available, enabling remarkable advancements in lung assessments while ensuring patient safety and comfort.

The FDA clearance, announced on September 4, 2025, opens the doors for widespread implementation across hospitals nationwide. This development is particularly significant as it aligns with the commitment to provide better clinical solutions for diagnosing pulmonary conditions. The Centers for Medicare & Medicaid Services (CMS) has also confirmed reimbursement for the CT:VQ™ under Category III CPT codes, which further facilitates access for patients needing this critical imaging without the complications associated with contrast agents.

The Technology Behind CT:VQ™

The CT:VQ™ technology allows clinicians to transform standard non-contrast chest CT scans into detailed quantitative lobar ventilation and perfusion maps. By employing a software-as-a-service model, it integrates seamlessly into existing radiology workflows, including DICOM-based PACS reporting systems. The solution efficiently utilizes the current infrastructure of approximately 14,500 CT scanners present in the U.S., allowing facilities that do not have nuclear medicine capabilities to offer advanced lung imaging services.

Dr. Andreas Fouras, the founder and CEO of 4DMedical, remarked, "CTVQ gives clinicians all the contrast—and none of the injections. With the FDA clearance and Medicare payment options, hospitals can now turn ordinary chest CTs into high-resolution ventilation-perfusion studies swiftly and without the complexities of new hardware requirements. It really is a breakthrough technology."

This technology is not just a convenience; it significantly improves the patient experience. Patients undergoing the CT:VQ™ imaging avoid the need for injections, completing their entire process in one session. The simplicity of the system allows radiologists to obtain high-resolution, quantitative V/Q maps directly through their standard PACS interfaces. These maps then provide critical data for pulmonologists working on various conditions such as pulmonary embolism (PE) evaluations, CTEPH assessments, COPD phenotyping, and bronchial lung volume reduction (BLVR) planning, among others.

Clinical Validation and Partnerships

The clinical validation for CT:VQ™ involved robust performance testing against the established SPECT imaging methods, expert radiologist consultations, and real-world applications involving diverse lung conditions. Notably, early clinical partnerships in the U.S., including reputable institutions such as Stanford University and Brooke Army Medical Center, have already begun to showcase the capabilities of this advanced technology. Preliminary findings from Brooke Army Medical Center were recently presented at the 2025 American Thoracic Society meeting, highlighting the clinical impact of this innovation.

About 4DMedical

Established as a leader in medical technology, 4DMedical Limited (ASX: 4DX) is dedicated to redefining respiratory health through cutting-edge imaging and artificial intelligence solutions. Their patented XV Technology powers several FDA-cleared products, including XV LVAS®, CT LVAS™, and now CT:VQ™, each delivering high-quality ventilation and perfusion analysis directly from non-contrast chest CT scans. As a cloud-based Software-as-a-Service provider, 4DMedical continues to enhance hospital efficiencies and patient care through seamless system integration.

In a notable strategic move, the acquisition of Imbio in 2023 has positioned 4DMedical at the forefront of comprehensive cardiopulmonary analysis. By combining ventilation, perfusion, and parenchymal assessments into one cohesive platform, they ensure a more streamlined and effective approach to respiratory health diagnostics.

To learn more about 4DMedical and its innovative solutions, visit 4dmedical.com.