CT:VQ™

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4DMedical's CT:VQ™ receives FDA 510(k) clearance; First-and-only CT-based VQ technology
Prnewswire· 2025-09-04 10:00
Core Insights - 4DMedical has received FDA 510(k) clearance for CT:VQ™, the first non-contrast ventilation–perfusion imaging solution, and Medicare has confirmed reimbursement for this technology under Category III CPT codes, enhancing access to this imaging method nationwide [1][4]. Company Overview - 4DMedical is a global medical technology company focused on transforming respiratory care through advanced imaging and artificial intelligence, with patented technologies that enable quantitative ventilation and perfusion analysis from non-contrast chest CT scans [6]. Technology and Implementation - CT:VQ converts standard non-contrast chest CTs into quantitative lobar ventilation and perfusion maps, integrating seamlessly with existing radiology workflows and utilizing the installed base of approximately 14,500 CT scanners in the U.S. [3][4]. - The technology allows hospitals to perform high-resolution ventilation–perfusion studies without the need for new hardware or complex workflows, making it accessible to facilities without nuclear medicine capabilities [4]. Clinical Validation and Partnerships - More than one million nuclear V/Q scans are performed annually in the U.S., and 4DMedical's CT:VQ has undergone clinical validation through quantitative performance testing against SPECT and real-world studies across various lung conditions [5]. - Early clinical partners include Stanford University and Brooke Army Medical Center, which have presented initial findings at the 2025 American Thoracic Society meeting [5].