/PRNewswire/ -- 4DMedical, a leader in advanced respiratory imaging, today announces U.S. Food and Drug Administration (FDA) 510(k) clearance for CT:VQ™, the world's first and only non-contrast, ventilation–perfusion (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..

/PRNewswire/ -- 先进呼吸成像领域的领导者4DMedical今天宣布，其CT:VQ™已获得美国食品药品监督管理局（FDA）的510(k)许可。CT:VQ™是全球首个且唯一的无对比剂通气-灌注（VQ）成像解决方案。与此同时，美国医疗保险和医疗补助服务中心（CMS）已确认CT:VQ可按第三类CPT代码获得报销；此项付款是在现有的胸部CT检查报销之外的额外支付。

4DMedical CT:VQ™ turns a routine chest CT into ventilation–perfusion imaging—no contrast required.

4DMedical CT:VQ™ 将常规胸部CT转化为通气-灌注成像——无需使用造影剂。

CT:VQ converts standard, non–contrast chest CTs into quantitative, lobar ventilation (V) and perfusion (Q) maps. Delivered as software–as–a–service, it integrates directly with routine radiology workflows (DICOM-based, PACS reporting) and leverages the U.S. installed base of approximately 14,

CT:VQ 将标准的非增强型胸部CT转化为定量的肺叶通气（V）和灌注（Q）图。以软件即服务的形式提供，它直接整合到常规放射科工作流程中（基于DICOM、PACS报告），并利用美国已安装的大约14,

500 CT

500 CT

scanners, bringing functional lung imaging to sites without nuclear medicine capacity.

扫描仪，将功能性肺成像带到没有核医学能力的地点。

'CT:VQ gives clinicians all the contrast—and none of the injections,' said

“CT:VQ为临床医生提供了所有的对比效果，而且无需注射。”

Andreas Fouras

安德烈亚斯·福拉斯

, 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–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.'.

，4DMedical的创始人兼首席执行官。 “在FDA批准和Medicare支付到位的情况下，任何拥有CT扫描仪的医院都可以在几分钟内将常规胸部CT变成高分辨率通气-灌注研究，而无需新的硬件或工作流程复杂性。‘突破性’这个词被过度使用，但我们相信CT:VQ前所未有的能力确实配得上这一描述。”

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.

CT:VQ 将常规的非对比胸部CT转化为可报销的V/Q研究，无需新硬件。患者无需注射，并在单次CT预约中完成整个过程。放射科医生随后会直接在PACS中接收到高分辨率、定量的V/Q图。这使肺科医生能够获取用于肺栓塞检查、慢性血栓栓塞性肺动脉高压评估、慢性阻塞性肺病分型、支气管镜肺减容术规划及持续监测的可行信息。

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..

由于CT：VQ可以在现有的扫描仪、医院和影像中心（包括那些没有核医学的机构）上运行，因此可以立即实施该技术以扩大社区和农村患者的访问范围。

More than one million nuclear V/Q scans are performed annually in the U.S. 4DMedical's clinical validation for CT:VQ included quantitative performance testing against SPECT, expert reader studies, and real–world cases across multiple lung conditions. Early U.S. clinical partners have included

美国每年进行超过一百万次核医学V/Q扫描。4DMedical的CT:VQ临床验证包括与SPECT的定量性能测试、专家阅片研究以及涵盖多种肺部状况的真实病例。美国早期的临床合作伙伴包括

Stanford University

斯坦福大学

and Brooke Army Medical Center, with the later presenting initial findings at the recent 2025 American Thoracic Society meeting.

以及布鲁克陆军医疗中心，后者在最近的2025年美国胸科学会会议上展示了初步研究结果。

About 4DMedical

关于4DMedical

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

4DMedical Limited（ASX:4DX）是一家全球医疗技术公司，通过先进的成像和人工智能技术变革呼吸系统护理。其获得专利的XV技术®为FDA批准的XV LVAS®、CT LVAS™和CT:VQ™提供支持，这些产品能够通过非对比胸部CT扫描实现定量通气和灌注分析。

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.

作为一种安全的、基于云的软件即服务提供，4DMedical 的解决方案与现有医院系统无缝集成，提高了医生的工作效率，并能够提供更加个性化的医疗服务。

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.

继2023年收购Imbio之后，4DMedical提供了最全面的心肺分析产品组合，在一个单一的云交付平台上涵盖通气、灌注和实质评估。