4DMedical secures regulatory approval in sixth market

• Medical technology company 4DMedical secured regulatory approval from the Therapeutic Goods Administration for its lung imaging software in Australia.
• The regulatory clearance expands the commercial availability of the ventilation-perfusion solution into its sixth global geographic market.
• The company aims to advance its submission to secure future Medicare Benefits Schedule reimbursement for nationwide clinical deployment.

4DMedical (ASX:4DX) announced that its non-contrast ventilation-perfusion imaging solution, CT:VQ, has received regulatory approval from the Therapeutic Goods Administration for commercial deployment across Australia.

The development follows existing regulatory clearance for the software-only platform in five other international markets, including the United States, the European Union, the United Kingdom, Canada and New Zealand.

The software solution allows clinicians to extract regional ventilation and perfusion data from standard chest scans without requiring contrast agents or nuclear medicine infrastructure.

The company is progressing a submission to the Medical Services Advisory Committee to secure future Medicare Benefits Schedule reimbursement for the platform.

Following the announcement, the 4DMedical share price was unchanged at $4.57.

The business previously established a commercial agreement with SimonMed Imaging to provide a high-volume reference model for its technological deployment.

This Australian clearance adds to the broader commercial strategy of utilising existing computed tomography infrastructure to establish functional lung assessments globally.