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Highlights

  • 4DMedical’s CT:VQ™ has received FDA 510(k) clearance, marking it as the first non-contrast CT-based ventilation-perfusion imaging technology.

  • The technology addresses an initial U.S. addressable market of more than USD $1.1 billion, with the potential to expand globally beyond USD $2.6 billion.

  • Extensive clinical validation demonstrated diagnostic equivalence to nuclear medicine scans while offering logistical and operational advantages.

4DMedical Limited (ASX:4DX), a developer of advanced respiratory imaging technologies, announced that its ventilation-perfusion product CT:VQ™ has received clearance from the U.S. Food and Drug Administration (FDA) under the 510(k) pathway. The approval establishes CT:VQ™ as the first non-contrast, CT-based imaging solution capable of generating quantitative ventilation and perfusion data directly from routine chest CT scans.

Ventilation-perfusion (VQ) scans are widely used to assess airflow and blood flow in the lungs, most commonly in the diagnosis of pulmonary embolism and in the management of conditions such as chronic thromboembolic pulmonary hypertension (CTEPH), chronic obstructive pulmonary disease (COPD), asthma, and in pre-surgical planning. Current nuclear medicine procedures require inhaled and injected radiotracers, specialised gamma cameras, and extended appointment times.

CT:VQ™ eliminates the need for radiotracers or contrast agents by extracting data from standard CT scans. The technology uses regional lung tissue motion and density changes to produce detailed ventilation and perfusion maps, streamlining workflow and expanding accessibility. With approximately 14,500 CT scanners installed across the United States, the solution offers broad clinical reach, including in facilities without nuclear medicine departments.

4DMedical has targeted a significant market opportunity. More than one million nuclear VQ scans are performed annually in the U.S., with an average reimbursement rate of USD $1,150 per procedure. This represents an addressable market exceeding USD $1.1 billion in the U.S. and more than USD $2.6 billion globally. The company anticipates CT:VQ™ can progressively capture this demand and, over time, displace traditional nuclear VQ imaging.

The FDA submission was underpinned by a comprehensive clinical validation package. Comparative testing with the current gold standard—single-photon emission computed tomography (SPECT)—showed equivalent diagnostic performance. Radiologists and pulmonologists reviewing cases reported strong alignment between CT:VQ™ and SPECT results, while patient case studies highlighted clearer imaging outputs free from common artifacts.

Initial clinical adoption is underway through contracts with U.S. healthcare centres such as Stanford University and Brooke Army Medical Center. Findings from early use have been presented at major scientific conferences, including the 2025 American Thoracic Society meeting, where CT:VQ™ demonstrated its potential not only in conventional VQ indications but also in disease monitoring, treatment planning, and screening applications.

On 1 September 2025, 4DMedical’s share price increased by 29.8% to AUD 0.74 per share.