• Regulatory clearance for CT:VQ, a non-contrast CT-based ventilation and perfusion analysis
• Potential to displace nuclear medicine VQ without changing clinical practice or infrastructure
• Reduces patient exposure to radioactive materials and increases diagnostic accuracy

4DMedical Limited (ASX:4DX) has reached a major milestone with the submission of its CT:VQ technology for FDA 510(k) clearance. CT:VQ is a software layer applied to a non-contrast CT scan of the lungs, providing detailed ventilation and perfusion analysis without the need for radioactive materials or contrast injections. The company's clinical evaluation studies have demonstrated that CT:VQ strongly correlates with SPECT VQ imaging, the current gold standard, while offering several advantages. CT:VQ has the potential to quickly displace nuclear medicine VQ without having to change clinical practice or replace existing infrastructure, reducing patient exposure to radioactive materials and increasing diagnostic accuracy. The reader performance study confirmed that clinicians consistently rated CT:VQ outputs as having good to excellent agreement with SPECT across all lung regions, affirming the interpretability and clinical actionability of the technology. Beyond displacing nuclear VQ, additional growth opportunities arise by extending VQ analysis to non-contrast CT-based imaging, dramatically increasing access to pulmonary perfusion assessment. With the regulatory submission, 4DMedical is poised to revolutionize lung imaging and improve patient care and workflows.

4DMedical is poised to revolutionize lung imaging and improve patient care and workflows with the submission of its CT:VQ technology for FDA clearance. The company's clinical evaluation studies have demonstrated the potential for CT:VQ to quickly displace nuclear medicine VQ without changing clinical practice or infrastructure, while reducing patient exposure to radioactive materials and increasing diagnostic accuracy.