FDA Clears Non-Contrast CT-Based Ventilation Perfusion Imaging

The emerging CT:VQ software, which generates quantitative ventilation perfusion mapping from non-contrast chest computed tomography (CT) scans, has garnered 510(k) clearance from the Food and Drug Administration (FDA).

With software as a service (SAAS) availability, CT:VQ facilitates direct delivery of high-resolution quantitative ventilation perfusion maps to radiologists in PACS, according to 4DMedical, the developer of the CT:VQ software.

The company noted that the quantitative ventilation perfusion maps provide enhanced insight into assessments for conditions such as chronic obstructive pulmonary disease (COPD), pulmonary embolism (PE) and chronic thromboembolic pulmonary hypertension (CTEPH).

4DMedical also pointed out that CT:VQ has been approved by the U.S. Centers for Medicare and Medicaid Services (CMS) for Category III CPT reimbursement, which provides additional reimbursement beyond that for the chest CT scan.

"CT:VQ gives clinicians all the contrast—and none of the injections," said Andreas Fouras, Ph.D, the founder and CEO of 4DMedical. "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."