Respiratory imaging technology company 4DMedical Limited (ASX:4DX) has received clearance for its CT-based ventilation product (CT LVAS) from the US Food and Drug Administration (FDA).
The CT LVAS clearance broadens the accessibility of functional lung imaging in the US
CT LVASTM 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 was chosen as the Company’s first market due to its high density of CT scanners per head of population. According to OECD data, the US install base for CT scanners is also material, with 43 CT scanners per million population (versus Australia at 70, France at 20, and Canada at 15 per million), and will therefore significantly broaden the accessibility of functional lung imaging for people in the U.S. living with lung disease.
Last week, the company announced the US Centres for Medicare & Medicaid Services (CMS) had approved reimbursement for 4DMedical’s XV LVAS at a rate of US$299 per procedure effective 1 January 2024. Following FDA clearance for CT LVAS, the company will adopt a similar reimbursement strategy by firstly applying to the American Medical Association (AMA) to establish a new, distinct, Category III CPT code to identify the use of CT LVAS amongst healthcare providers and payers, and then seek to have the procedure reimbursed by public and private health insurance schemes.
I am excited by this progress in our commercialisation and the impact that FDA clearance for CT LVAS will provide caregivers and patients,” 4DMedical MD/CEO and Founder, Andreas Fouras, said.
“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.”
