4DMedical clears Australia for contrast-free lung function imaging
New CapabilitiesCT:VQ pulls ventilation and blood-flow maps from a routine chest CT, skipping radioactive tracers and dye
June 29th, 2026: Australia approves CT:VQ for home marketNew here? Follow stories to track developments over time. Create a free account to get updates when stories you care about change.
Overview
Updated Jun 29A patient with breathing trouble usually needs a nuclear medicine scan to see how air and blood move through the lungs. That means radioactive tracers, special cameras, and a clinic that has them. 4DMedical's CT:VQ skips all of it.
On June 29, 2026, Australia's drug and device regulator cleared the software for sale at home. It reads the same data from an ordinary chest CT scan. Hospitals without nuclear medicine units can now get functional lung maps from a machine they already own.
Why it matters
Functional lung diagnostics that once needed nuclear medicine units can now run on any standard CT scanner, widening access for patients far from specialist centers.
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People Involved
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A Melbourne-based respiratory imaging company that extracts lung-function data from standard scans using software.
Australia's regulator for medicines and medical devices, which decides what can be sold in the country.
Timeline
May 2020 June 2026
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Australia approves CT:VQ for home market
Latest RegulatoryThe TGA approves CT:VQ and adds it to the national register, clearing it for commercial use across Australia. It joins clearances in the US, EU, UK, Canada, and New Zealand.
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FDA clears CT:VQ in the United States
Regulatory4DMedical wins FDA 510(k) clearance for CT:VQ, billed as the first non-contrast ventilation-perfusion imaging tool drawn from a standard CT scan.
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First US clearance for XV lung imaging
RegulatoryThe FDA clears 4DMedical's XV LVAS, which maps lung function from X-ray fluoroscopy. It is the platform later products build on.
Historical Context
2 moments from history that rhyme with this story — and how they unfolded.
HeartFlow FFR-CT clearance (2014)
HeartFlow won FDA clearance for software that calculates blood-flow significance of coronary blockages from a standard CT scan. It promised to replace an invasive catheter test for many heart patients. The clinical case was strong from the start.
Cardiologists welcomed the tool, but uptake depended on payers agreeing to cover it.
Adoption grew over the following decade as reimbursement expanded, and the company reached a public listing in 2024.
Like CT:VQ, it extracts functional data from an ordinary CT scan. Its history shows clearance is the start, and reimbursement decides how fast doctors actually switch.
CT pulmonary angiography displaces nuclear VQ scans (1990s-2000s)
To diagnose blood clots in the lungs, hospitals long relied on nuclear medicine VQ scans. As CT scanners improved, CT pulmonary angiography became the faster, more available first-line test. Many radiology departments shifted their default within a decade.
CT angiography became the go-to test for suspected pulmonary embolism at most hospitals.
Nuclear VQ scans narrowed to specific cases, such as patients who cannot receive contrast dye.
It shows lung diagnostics can move from nuclear medicine to CT when CT is more available. CT:VQ pushes that shift further by removing contrast and tracers entirely.
