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4DMedical clears Australia for contrast-free lung function imaging

4DMedical clears Australia for contrast-free lung function imaging

New Capabilities

CT:VQ pulls ventilation and blood-flow maps from a routine chest CT, skipping radioactive tracers and dye

Today: Australia approves CT:VQ for home market

Overview

A 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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Key Indicators

6
Markets cleared
CT:VQ now holds regulatory clearance in the US, EU, UK, Canada, New Zealand, and Australia.
0
Radiotracers or dyes needed
The scan uses no injected contrast and no radioactive tracer.
$150M
Institutional backing raised
4DMedical secured the funding as its US commercial rollout ramped up.
~10 mo
FDA clearance to home approval
US clearance came in September 2025; Australian approval followed in June 2026.

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People Involved

Organizations Involved

Timeline

May 2020 June 2026

3 events Latest: Today
  1. Australia approves CT:VQ for home market

    Today Regulatory

    The 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.

  2. FDA clears CT:VQ in the United States

    Regulatory

    4DMedical wins FDA 510(k) clearance for CT:VQ, billed as the first non-contrast ventilation-perfusion imaging tool drawn from a standard CT scan.

  3. First US clearance for XV lung imaging

    Regulatory

    The 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.

November 2014

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.

Then

Cardiologists welcomed the tool, but uptake depended on payers agreeing to cover it.

Now

Adoption grew over the following decade as reimbursement expanded, and the company reached a public listing in 2024.

Why this matters now

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.

1990s-2000s

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.

Then

CT angiography became the go-to test for suspected pulmonary embolism at most hospitals.

Now

Nuclear VQ scans narrowed to specific cases, such as patients who cannot receive contrast dye.

Why this matters now

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.

Sources

(5)