The US Food and Drug Administration (FDA) has granted 510(k) clearance to 4DMedical’s non-contrast, computed tomography (CT)-based ventilation-perfusion imaging technology, CT:VQ, for respiratory diagnostics.
This technology provides quantitative assessments of both ventilation and perfusion from standard chest CT scans.
4DMedical’s submission was supported by a clinical validation package that spanned a variety of lung conditions.
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According to the company, VQ scans, which are instrumental in diagnosing pulmonary embolism and assessing lung function in various respiratory diseases, traditionally require two scans to evaluate airflow and blood flow in the lungs.
By measuring lung tissue motion and changes in density, the technology produces maps of ventilation and perfusion.
The new technology simplifies the imaging process, reducing the 45-90 minute procedure to the duration of a standard CT scan and eliminating the need for radiotracers.
This not only streamlines scheduling and enhances patient access but also alleviates the complex handling and regulatory challenges associated with traditional nuclear VQ imaging.
Furthermore, CT:VQ’s compatibility with the network of CT scanners, approximately 14,500 across the US, expands the reach of VQ imaging, added the company.
4DMedical’s clinical testing has demonstrated that the technology can deliver diagnostic outcomes on par with single-photon emission computed tomography (SPECT), the current benchmark in nuclear ventilation-perfusion imaging.
The company has secured commercial contracts for research use of CT:VQ at US healthcare institutions, including Brooke Army Medical Center and Stanford University.
4DMedical is focused on respiratory care using imaging and AI. The company’s XV Technology is aimed at transforming traditional scans into functional insights, enabling physicians to identify and monitor lung disease early.
The company’s software portfolio includes the XV Lung Ventilation Analysis Software (XV LVAS), alongside CT LVAS.
