4DMEDICAL Ltd Wins TGA Approval for Lung Imaging Tool in Australia
4DMedical (ASX:4DX) has secured TGA approval for its CT:VQ™ lung imaging solution, unlocking commercial deployment across Australia's world-leading CT scanner network and opening a Medicare reimbursement pathway.
Key Takeaways
- 4DMedical has received TGA approval for CT:VQ™ and inclusion in the Australian Register of Therapeutic Goods, clearing the path for commercial deployment across Australia for the first time.
- Australia ranks second globally for CT scanner density at more than 74 scanners per million people, giving CT:VQ™ an immediately accessible infrastructure base that requires no new capital investment from healthcare providers.
- CT:VQ™ now holds regulatory approval across six jurisdictions — the US, EU, UK, Canada, New Zealand and Australia — with US deployment already active at Stanford, Cleveland Clinic, UC San Diego Health, University of Chicago Medicine and University of Miami.
- Peer-reviewed clinical data published in the world's leading respiratory medicine journal shows CT:VQ-guided patient selection achieving a 76% surgical response rate versus 46% under current methods, forming the evidentiary backbone for the forthcoming MSAC Medicare reimbursement submission.
- 4DMedical operates a SaaS delivery model and holds pharmaceutical imaging contracts with GSK and AstraZeneca, with management framing 2026 as a defining commercial year across both home and international markets.
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