Australian medical technology company 4DMedical has received the US Food and Drug Administration (FDA) 510(k) clearance for its CT:VQ technology.
The CT:VQ technology is intended to convert standard non-contrast chest computed tomography (CT) scans into detailed lobar ventilation and perfusion maps.
4DMedical said that its CT:VQ is the world’s first CT-based ventilation-perfusion (VQ) imaging technology, and provides advanced imaging in both urban and rural settings.
In addition to the FDA approval, the US Centres for Medicare & Medicaid Services (CMS) has confirmed reimbursement for CT:VQ under Category III CPT codes.
The development paves the way for enhanced access to advanced respiratory imaging across the US, said the medical technology company.
4DMedical founder and CEO Andreas Fouras said: “CT:VQ gives clinicians all the contrast, and none of the injections.
“With FDA clearance and Medicare payment in place, any hospital with a CT scanner can turn a routine chest CT into a high–resolution ventilation–perfusion study in minutes, without new hardware or workflow complexity.
“The word ‘breakthrough’ is overused, but we believe the unprecedented capabilities of CT:VQ qualify for that description.”
Offered as software-as-a-service, CT:VQ is said to integrate seamlessly with existing radiology workflows, using around 14,500 CT scanners installed nationwide.
The technology brings functional lung imaging to facilities lacking nuclear medicine capabilities, thereby enhancing diagnostic options for various pulmonary conditions.
Its ability to transform routine CT appointments into reimbursable V/Q studies will benefit patients, eliminating the need for injections or additional hardware.
The technology provides radiologists with high-resolution V/Q maps directly in PACS, aiding pulmonologists in diagnosing and monitoring several respiratory conditions.
4DMedical said that its CT:VQ has undergone rigorous clinical validation, including performance tests against single-photon emission computed tomography (SPECT) and real-world cases across several lung conditions.
Early clinical partners in the US for the technology include Stanford University and Brooke Army Medical Center.
