4DMedical Limited (ASX:4DX) shares surged 13.42% on 18 September 2026, closing at A$4.31, up A$0.51 for the day. The rally builds on strong momentum following the company's FY26 full-year results, released on 28 August 2026, which detailed rapid commercial progress for its flagship CT:VQ™ lung imaging technology across the United States, Europe and Australia.

What Drove 4DMedical Shares Higher

The FY26 results, combined with continued positive news flow on academic medical centre adoption, outpatient network rollout and expanding regulatory approvals for CT:VQ™, appear to have driven sustained buying interest into 18 September 2026, culminating in the day's double-digit percentage gain.

Company Overview

4DMedical is a global medical technology company specialising in respiratory imaging, built around its patented XV Technology®, which transforms standard CT scans into detailed functional lung assessments. Its flagship product, CT:VQ™, is the world's first and only non-contrast, CT-based ventilation-perfusion imaging technology, and was cleared by the U.S. FDA in September 2025 with CMS reimbursement confirmed at US$650.50 per scan.

In its FY26 results, 4DMedical reported Operating Revenue of $7.1 million, up 21% on FY25, with gross margins exceeding 90%. The company delivered SaaS products at 540 sites globally, representing 39% growth year-on-year, and produced 344,075 scans during the year, up 77% on FY25, including a record 105,970 scans in the fourth quarter alone. The company closed the year with a cash balance of $278.0 million, providing significant runway for its strategic objectives.

Commercially, CT:VQ™ gained rapid traction among leading U.S. Academic Medical Centers, including Stanford, Cleveland Clinic, UC San Diego Health, University of Miami and University of Chicago Medicine, all operating under full commercial terms by 30 June 2026. The technology also entered the U.S. outpatient market through a three-year agreement with SimonMed Imaging's 170-site network, and secured a major distribution deal with Philips covering the United States and Canada, underwritten by contractual minimum revenue targets. CT:VQ™ has now been authorised in six markets — the U.S., EU, UK, Canada, New Zealand and Australia.

The company also expanded its clinical evidence base, with publication in the American Journal of Respiratory and Critical Care Medicine showing CT:VQ™-guided patient selection lifted response rates to lung Volume reduction surgery from 46% to 76%. A new clinical program called CLEAR, anchored at Massachusetts General Hospital, is targeting the acute pulmonary embolism market, an opportunity management says lifts the total obtainable U.S. market for CT:VQ™ to approximately US$3 billion. Strategically, 4DMedical acquired European AI imaging company contextflow and secured a significant German lung cancer screening contract through Curagita covering roughly 25,000 screening procedures across 25 sites, including Heidelberg University's Thoraxklinik.

Bull Case

Scan volumes grew 77% year-on-year and site count grew 39%, with CT:VQ™ now authorised in six major healthcare markets and adopted by some of the most demanding Academic Medical Centers in the U.S., which management describes as validating the broader commercialisation strategy.

The CLEAR program's push into the acute pulmonary embolism market alone is estimated to lift 4DMedical's U.S. obtainable market from roughly US$500 million to US$3 billion, materially increasing the long-term revenue opportunity.

With $278 million in cash and confirmed CMS reimbursement of US$650.50 per scan, the company has both the runway and the payment certainty to continue funding commercialisation without near-term existential Capital risk.

Beyond CT:VQ™, the company's pharmaceutical partnerships with AstraZeneca and GSK, its European contextflow platform, and its RevealDx and Azra AI partnerships create a broader, connected cardiopulmonary care ecosystem that extends 4DMedical's addressable opportunity.

Bear Case

Despite 21% revenue growth, 4DMedical's adjusted net loss for FY26 was $32.9 million, and the statutory loss including a non-cash Fair Value charge related to the Pro Medicus Facility was substantially higher at $164.6 million, underscoring that profitability remains some way off.

At $7.1 million in FY26 operating revenue, the company's growth narrative is still being priced heavily on future potential rather than current earnings, leaving the stock vulnerable to any slowdown in adoption metrics.

Management noted that SimonMed's 170 sites are not included in the reported 540-site count, meaning some of the bullish commentary reflects anticipated rather than already-recognised commercial activity.

The company is scaling U.S. AMC adoption, a new outpatient network, a Philips distribution deal, European operations via contextflow, and new AI partnerships all at once, a broad simultaneous expansion that carries integration and management-bandwidth risk.

Key Takeaways

4DMedical's 13.42% rally on 18 September 2026 reflects continued confidence in the company's rapidly scaling CT:VQ™ commercialisation, underpinned by a strong cash position and expanding regulatory footprint. The stock remains a high-growth, pre-profitability story, meaning execution on the FY27 "conversion" phase will be the key determinant of whether current momentum can be sustained.