4D Medical secures regulatory clearance in Australia for imaging software
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The news: Respiratory imaging company 4D Medical has received regulatory clearance from the Australian Therapeutics Goods Administration (TGA) for its imaging software CT:VQ, allowing immediate commercialisation across Australia.
The context: Australia now joins a growing list of markets where CT:VQ is cleared for commercial sale, alongside the US, the European Union, the UK, Canada and New Zealand. The regulatory milestone supports the company’s strategy to establish the software as the new global standard for functional lung assessments.
4D Medical stated that Australia is uniquely positioned for rapid adoption due to its extensive computed tomography (CT) infrastructure, adding that the nation ranks second globally for CT scanner density, boasting more than 74 scanners per million people.
The company also confirmed it will actively pursue an application for Medicare Benefits Schedule reimbursement for the CT:VQ platform.
The CT:QV technology enables radiologists to extract detailed regional ventilation data directly from a standard chest CT scan without the use of chemical injections or radiotracers.
What they said: “With TGA approval secured and a reimbursement pathway ahead, 2026 continues to be a defining year for 4D Medical as we expand access to next-generation respiratory imaging for patients, clinicians and health systems around the world,” CEO Andreas Fouras said.
The source: ASX
