4DMedical LimitedPrivate▲ Positive
Regulationrelevance
TGA approval enables commercial deployment in Australia, expanding market access.
4DMedical Limited has received approval from Australia's Therapeutic Goods Administration for its CT:VQ lung imaging technology, enabling commercial deployment across the country. The non-contrast ventilation-perfusion imaging solution derives regional lung function information from routine chest CT scans and was previously cleared by the U.S. FDA in September 2025, as well as regulators in the EU, UK, Canada, and New Zealand. The Software-as-a-Service model converts chest CTs into regional ventilation and perfusion maps without injected contrast agents, radiotracers, or radioactive isotopes, allowing hospitals and clinics with existing CT imaging to offer functional lung assessments. For the financial year ended June 30, 2025, 4DMedical reported total revenue of $5.85 million, up 56% from $3.75 million in 2024, and held cash and cash equivalents of $6.88 million. Shares closed Monday on the Australian Stock Exchange at $4.59, up 10.34%.
TGA approval enables commercial deployment in Australia, expanding market access.