4D Medical (ASX:4DX) Soars After FDA Nod for Lung Imaging Tool All Ordinaries

Highlights

• 4D Medical secures US FDA clearance for CT-based lung imaging device

• The CT:VQ system offers a non-invasive diagnostic approach without contrast agents

• Pro Medicus and Lumos Diagnostics also advance healthcare tech initiatives in the US

4D Medical Ltd (ASX:4DX), listed on the All Ordinaries, has achieved a regulatory milestone with the United States Food and Drug Administration granting clearance for its CT:VQ imaging platform. The device offers a novel solution for assessing ventilation and perfusion in the lungs, using standard CT scans without the need for contrast agents. This marks a significant development in respiratory diagnostics and enables broader clinical access to the tool across healthcare settings.

The CT:VQ system stands out as the first non-contrast, CT-based ventilation-perfusion imaging method globally. Traditionally, these scans have relied on nuclear medicine approaches, which are often less accessible, especially in rural or community hospitals. By leveraging existing CT scanner infrastructure, the technology is positioned for widespread clinical adoption in facilities that lack dedicated nuclear imaging capabilities.

How does CT:VQ enhance lung disease diagnosis?

Ventilation-perfusion (VQ) imaging is commonly used to detect pulmonary embolism and evaluate conditions like asthma and chronic obstructive pulmonary disease. CT:VQ creates comprehensive, high-resolution maps of airflow and blood flow within the lungs, helping identify imbalances and physiological abnormalities.

The absence of contrast media not only reduces patient exposure to potentially harmful agents but also expands the usability of the tool in a broader range of patients and clinical settings. 4D Medical asserts that its platform could eventually displace existing nuclear VQ scan systems across the US healthcare network.

What is Pro Medicus doing in the US healthcare sector?

Pro Medicus Ltd (ASX:PME) has made further inroads into the US government health system by receiving Authority to Operate (ATO) status from the Department of Veterans Affairs. This authorisation confirms that its cloud-based Visage 7 platform meets stringent federal cybersecurity and data integrity requirements.

With this clearance, Pro Medicus can now establish reference sites within the veterans’ health network and scale its platform across other regional centres. Visage 7 is designed to streamline medical imaging access and analysis, improving diagnostic efficiency for clinicians.

What’s next for Lumos Diagnostics and paediatric flu testing?

Lumos Diagnostics (ASX:LDX) has secured new funding from the US Biomedical Advanced Research and Development Authority (BARDA) to launch a paediatric study for its Febridx testing device. While Febridx already holds FDA approval for adult use, the next phase of development aims to support Clinical Laboratory Improvement Amendments (CLIA) waiver clearance for children between the ages of two and twelve.

The test provides a rapid assessment to distinguish between bacterial and viral infections using a small blood sample from a finger prick. A CLIA waiver would allow its use in non-laboratory environments such as primary care clinics and pharmacies, significantly expanding its market reach in time for seasonal flu surges.

What advancements are happening in MRI-guided cardiac care?

Imricor Medical Systems (ASX:IMR) has formally submitted its Vision-MR catheter system to the FDA for review. The catheter enables MRI-guided cardiac ablation, an innovative technique for treating heart rhythm disorders. Unlike traditional x-ray-based methods, this platform eliminates radiation exposure and aims to provide a fully integrated, real-time imaging experience.

The Vision-MR system is complemented by the North Star navigation platform, which is also under regulatory review. If approved, this could position Imricor at the forefront of MRI-guided electrophysiology procedures in the US market.

How are other health and biotech players performing?

Several ASX-listed life sciences companies reported financial and clinical updates:

• Mesoblast Ltd (ASX:MSB) highlighted rising revenue from its stem cell therapy for paediatric graft-versus-host disease, following FDA approval last year.

• Botanix Pharmaceuticals Ltd (ASX:BOT) delivered its first sales for Sofdra, a treatment for excessive underarm sweating.

• EZZ Life Science (ASX:EZZ) reported expanded product offerings and marked its entry into the US e-commerce market.

• Adherium Ltd (ASX:ADR) and Atomos Ltd (ASX:AMS) also updated on revenue and loss improvements across respiratory and diagnostic testing devices respectively.

This range of developments underlines the growing footprint of Australian healthcare and biotech companies in the US diagnostics and therapeutics markets.