4DMedical receives US FDA clearance for its CT-based ventilation product

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Respiratory imaging technology company 4DMedical Limited (ASX:4DX) has US FDA-received clearance for its CT-based ventilation product (CT LVAS).

CT LVAS clearance broadens the accessibility of functional lung imaging in the US. CT LVAS provides an almost identical report to 4DMedical’s proven, FDA-cleared XV LVAS product but utilises widely available Computed Tomography (CT) imaging infrastructure instead of X-ray equipment, providing clinicians and patients with greater access to XV Technology.

FDA clearance follows the rollout of CT LVAS in Australia, which the company chose as its first market due to its high density of CT scanners per head of population.

4DMedical managing director, CEO and founder Andreas Fouras said, "I am excited by this progress in our commercialisation and the impact that FDA clearance for CT LVAS will provide caregivers and patients. As we head to RSNA, I am thrilled that reimbursement has been approved for our XV LVAS product, and to now also share that we have clearance for CT LVAS in the US, which, both in their own rights, create material impetus for doctors and patients to adopt our technology. The clearance for CT LVAS offers further validation of our development and represents significant progress towards commercial release of our CT:VQ technology."