{"id":31581,"date":"2025-09-04T11:30:19","date_gmt":"2025-09-04T11:30:19","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/4dmedicals-ctvq-receives-fda-510k-clearance-first-and-only-ct-based-vq-technology\/"},"modified":"2025-09-04T11:30:19","modified_gmt":"2025-09-04T11:30:19","slug":"4dmedicals-ctvq-receives-fda-510k-clearance-first-and-only-ct-based-vq-technology","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=31581","title":{"rendered":"4DMedical’s CT:VQ\u2122 receives FDA 510(k) clearance; First-and-only CT-based VQ technology"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Medicare confirms reimbursement, unlocking nationwide access to\u00a0non-contrast ventilation\u2013perfusion imaging from routine chest CT<\/b><\/p>\n

LOS ANGELES<\/span><\/span>, Sept. 4, 2025<\/span><\/span> \/PRNewswire\/ — 4DMedical, a leader in advanced respiratory imaging, today announces U.S. Food and Drug Administration (FDA) 510(k) clearance for\u00a0CT:VQ\u2122, the world’s first and only non-contrast, ventilation\u2013perfusion (VQ) imaging solution. In parallel, the U.S. Centers for Medicare & Medicaid Services (CMS) has confirmed reimbursement for CT:VQ under Category III CPT codes; this payment is in addition to existing reimbursement for the underlying chest CT.<\/p>\n

\"4DMedical<\/a>
4DMedical CT:VQ\u2122 turns a routine chest CT into ventilation\u2013perfusion imaging\u2014no contrast required.<\/span> <\/div>\n

CT:VQ converts standard, non\u2013contrast chest CTs into quantitative, lobar ventilation (V) and perfusion (Q) maps. Delivered as software\u2013as\u2013a\u2013service, it integrates directly with routine radiology workflows (DICOM-based, PACS reporting) and leverages the U.S. installed base of approximately 14,500 CT<\/span> scanners, bringing functional lung imaging to sites without nuclear medicine capacity.<\/p>\n

“CT:VQ gives clinicians all the contrast\u2014and none of the injections,” said Andreas Fouras<\/span>, PhD, 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\u2013resolution ventilation\u2013perfusion 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.”<\/p>\n

CT:VQ transforms a routine non-contrast chest CT into a reimbursable V\/Q study, eliminating the need for new hardware. Patients skip injections and complete the entire process in a single CT appointment. Radiologists then receive high-resolution, quantitative V\/Q maps directly in PACS. This allows pulmonologists to gain actionable information for PE workups, CTEPH assessment, COPD phenotyping, BLVR planning, and ongoing monitoring. Since CT:VQ operates on existing scanners, hospitals and imaging centers, including those without nuclear medicine, the technology can be implemented to immediately expand access to community and rural patients.<\/p>\n

More than one million nuclear V\/Q scans are performed annually in the U.S. 4DMedical’s clinical validation for\u00a0CT:VQ included quantitative performance testing against SPECT, expert reader studies, and real\u2013world cases across multiple lung conditions. Early U.S. clinical partners have included Stanford University<\/span> and Brooke Army Medical Center, with the later presenting initial findings at the recent 2025 American Thoracic Society meeting.<\/p>\n

About 4DMedical<\/b>
4DMedical Limited (ASX:4DX) is a global medical technology company transforming respiratory care through advanced imaging and artificial intelligence. Its patented XV Technology\u00ae powers the FDA-cleared XV LVAS\u00ae, CT LVAS\u2122, and CT:VQ\u2122, which deliver quantitative ventilation and perfusion analysis from non-contrast chest CT scans.<\/p>\n

Delivered as secure, cloud-based Software-as-a-Service, 4DMedical’s solutions integrate seamlessly with existing hospital systems, improving physician productivity and enabling more personalized care.<\/p>\n

Following its 2023 acquisition of Imbio, 4DMedical delivers the most comprehensive cardiopulmonary analysis portfolio, spanning ventilation, perfusion, and parenchymal assessment on a single, cloud-delivered platform.<\/p>\n

Learn more at www.4dmedical.com<\/a><\/p>\n

Photo – https:\/\/mma.prnasia.com\/media2\/2764429\/4DMedical_CT_VQ_Non_Contrast_Lung_Ventilation_Perfusion.jpg?p=medium600<\/a>
Logo – https:\/\/mma.prnasia.com\/media2\/2730645\/4DMedical_Logo.jpg?p=medium600<\/a><\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Medicare confirms reimbursement, unlocking nationwide access to\u00a0non-contrast ventilation\u2013perfusion imaging from routine chest CT<\/b><\/p>\n

LOS ANGELES<\/span><\/span>, Sept. 4, 2025<\/span><\/span> \/PRNewswire\/ — 4DMedical, a leader in advanced respiratory imaging, today announces U.S. Food and Drug Administration (FDA) 510(k) clearance for\u00a0CT:VQ\u2122, the world’s first and only non-contrast, ventilation\u2013perfusion (VQ) imaging solution. In parallel, the U.S. Centers for Medicare & Medicaid Services (CMS) has confirmed reimbursement for CT:VQ under Category III CPT codes; this payment is in addition to existing reimbursement for the underlying chest CT.<\/p>\n

\"4DMedical<\/a>
4DMedical CT:VQ\u2122 turns a routine chest CT into ventilation\u2013perfusion imaging\u2014no contrast required.<\/span> <\/div>\n

CT:VQ converts standard, non\u2013contrast chest CTs into quantitative, lobar ventilation (V) and perfusion (Q) maps. Delivered as software\u2013as\u2013a\u2013service, it integrates directly with routine radiology workflows (DICOM-based, PACS reporting) and leverages the U.S. installed base of approximately 14,500 CT<\/span> scanners, bringing functional lung imaging to sites without nuclear medicine capacity.<\/p>\n

“CT:VQ gives clinicians all the contrast\u2014and none of the injections,” said Andreas Fouras<\/span>, PhD, 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\u2013resolution ventilation\u2013perfusion 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.”<\/p>\n

CT:VQ transforms a routine non-contrast chest CT into a reimbursable V\/Q study, eliminating the need for new hardware. Patients skip injections and complete the entire process in a single CT appointment. Radiologists then receive high-resolution, quantitative V\/Q maps directly in PACS. This allows pulmonologists to gain actionable information for PE workups, CTEPH assessment, COPD phenotyping, BLVR planning, and ongoing monitoring. Since CT:VQ operates on existing scanners, hospitals and imaging centers, including those without nuclear medicine, the technology can be implemented to immediately expand access to community and rural patients.<\/p>\n

More than one million nuclear V\/Q scans are performed annually in the U.S. 4DMedical’s clinical validation for\u00a0CT:VQ included quantitative performance testing against SPECT, expert reader studies, and real\u2013world cases across multiple lung conditions. Early U.S. clinical partners have included Stanford University<\/span> and Brooke Army Medical Center, with the later presenting initial findings at the recent 2025 American Thoracic Society meeting.<\/p>\n

About 4DMedical<\/b>
4DMedical Limited (ASX:4DX) is a global medical technology company transforming respiratory care through advanced imaging and artificial intelligence. Its patented XV Technology\u00ae powers the FDA-cleared XV LVAS\u00ae, CT LVAS\u2122, and CT:VQ\u2122, which deliver quantitative ventilation and perfusion analysis from non-contrast chest CT scans.<\/p>\n

Delivered as secure, cloud-based Software-as-a-Service, 4DMedical’s solutions integrate seamlessly with existing hospital systems, improving physician productivity and enabling more personalized care.<\/p>\n

Following its 2023 acquisition of Imbio, 4DMedical delivers the most comprehensive cardiopulmonary analysis portfolio, spanning ventilation, perfusion, and parenchymal assessment on a single, cloud-delivered platform.<\/p>\n

Learn more at www.4dmedical.com<\/a><\/p>\n

Photo – https:\/\/mma.prnasia.com\/media2\/2764429\/4DMedical_CT_VQ_Non_Contrast_Lung_Ventilation_Perfusion.jpg?p=medium600<\/a>
Logo – https:\/\/mma.prnasia.com\/media2\/2730645\/4DMedical_Logo.jpg?p=medium600<\/a><\/p>\n

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