Highlights

  • 4DMedical shares climbed 1,712% in six months following FDA clearance and CMS reimbursement for CT:VQ™.
  • Multiple single-day gains above 35% occurred in September 2025 as regulatory milestones were announced.
  • A AUD 150 million institutional placement in January 2026 supported plans to scale U.S. commercialisation.

4DMedical Ltd (ASX:4DX) has delivered one of the most pronounced share price moves on the Australian market over the past six months, with its stock rising 1,712% during the period. The rally followed a sequence of regulatory approvals, reimbursement confirmation and capital raising activity that reshaped the company’s commercial outlook, particularly in the United States.

Regulatory Approval as the Initial Catalyst

The first major trigger for the rally emerged on 1 September 2025, when 4DMedical announced that its ventilation-perfusion imaging product, CT:VQ™, received U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance enabled the company to market the technology across the U.S. healthcare system.

CT:VQ™ is positioned as a non-contrast, CT-based ventilation-perfusion imaging solution. The FDA submission was supported by clinical validation data across multiple lung conditions. At the time of the announcement, 4DMedical highlighted that more than one million nuclear VQ scans are performed annually in the U.S., representing an initial addressable market of USD 1.1 billion.

Shares rose 35.97% on 1 September and added a further 50% on 3 September as market attention turned toward the scale of the U.S. opportunity.

Reimbursement Confirmation Accelerates Momentum

Momentum continued on 3 September 2025 after the U.S. Centers for Medicare & Medicaid Services (CMS) confirmed reimbursement for CT:VQ™. The product was assigned a New Technology Ambulatory Payment Classification, with reimbursement set at USD 650.50 per scan under the Hospital Outpatient Prospective Payment System.

CMS confirmed that the reimbursement would be paid in addition to the standard chest CT scan payment. The announcement reduced uncertainty around payment pathways for hospitals and imaging centres and supported integration of CT:VQ™ into routine clinical workflows. The stock recorded another sharp move following the update.

Commercial Partnerships Broaden Market Reach

On 8 September 2025, 4DMedical announced a series of commercial and clinical collaborations. These included a lung health screening program in Brazil with a global pharmaceutical partner, a pilot deployment of its imaging portfolio at Royal Melbourne Hospital, and a multi-year agreement with Spectrum Medical Imaging to support Australia’s National Lung Cancer Screening Program.

The shares rose 49.52% on the day, extending the upward trend that had formed earlier in the month.

Capital Raise Supports U.S. Expansion

The rally extended into January 2026. On 15 January, 4DMedical confirmed commitments for a AUD 150 million institutional placement priced at AUD 3.80 per share. The placement attracted new global long-only investors and was supported by existing shareholders.

On the same day, the share price closed 5.59% higher at AUD 4.53. Over six months, the stock gained 1,712%, while the one-year increase reached 771.15%, as regulatory clearance, reimbursement certainty and funding capacity combined to drive sustained market interest.