Posted: 2 September 2025
4D Medical announced that the US Food and Drug Administration had granted 510(k) clearance for its computed tomography ventilation-perfusion (CT VQ) scan.
According to the company, CT VQ is the “first non-contrast imaging modality capable of delivering quantitative ventilation and perfusion analysis directly from standard chest CT scans”. VQ scans are commonly used to detect pulmonary embolism (lung blood clots), as well as to assess chronic thrombo-embolic pulmonary hypertension (CTEPH), other respiratory conditions, and for surgical planning in lung procedures.
The company highlighted that more than one million nuclear VQ scans are performed annually in the United States, generating an estimated reimbursement market of US$1.1 billion, with each scan averaging US$1,150.
4D Medical managing director Professor Andreas Fouras described the clearance as a landmark achievement: “FDA clearance of CT VQ is a defining milestone for 4D Medical and for lung health.”
“For the first time in history, doctors can order a lung perfusion scan without requiring their patients to be injected with any radioactive tracer or contrast media,” Prof Fouras said. “And unlike historical advancements in medical imaging, such as the introduction of [magnetic resonance imaging], this technology is instantly compatible with an install base of 14,500 CT scanners already deployed across the US.”
“With FDA clearance now secured, 4D Medical is positioned to accelerate the commercial rollout of CT VQ across the United States,” Prof Fouras added. “The company will engage with leading healthcare providers, academic centres, and strategic partners, to integrate this groundbreaking technology into clinical practice, supporting a shift toward safer, more efficient, and more accessible respiratory care.”
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