Melbourne, March 30, 2026, 05:09 AEDT
- 4DMedical on Friday announced CT:VQ has clinched CE mark clearance in the EU, while also raising A$83 million through a private placement, pricing shares at A$5.90 each.
- The company said it expects the proceeds to bankroll its European launch, projecting pro forma cash at A$289 million as of Dec. 31, 2025.
- Mayo Clinic rolled out CT:VQ on March 25, marking 4DMedical’s sixth U.S. academic medical center site since the FDA cleared the technology in September 2025.
4DMedical disclosed in a Friday filing that its CT:VQ technology secured European Union CE mark certification. The Australian medtech also said it had raised A$83 million from institutional investors, a boost to fund its European ambitions. Shares ended the day at A$6.28, having hit A$7.55 earlier in the session.
The timing comes into play as 4DMedical looks to build on recent U.S. hospital contracts and push for wider commercial uptake. According to the company, CT:VQ assesses how air and blood flow throughout the lungs using regular non-contrast CT scans—skipping the radiotracers needed for classic nuclear V/Q imaging.
Europe’s a major market. In its filing, 4DMedical sized up the EU opportunity at over 450 million people and about 400,000 nuclear V/Q scans annually, and pointed to an established base of CT scanners. The key point: the company is moving software, not hardware.
Shares in the single-tranche placement went for A$5.90 apiece—marking a 6.1% dip from where they finished on March 26, but still 12.3% above the five-day VWAP, a standard market gauge. Roughly 14.1 million shares are expected to be issued. Settlement is slated for April 1, with the new shares scheduled to hit the boards on April 2.
Chief Executive Andreas Fouras described the CE mark as “a significant milestone,” saying it unlocks access to one of the world’s largest healthcare markets. He also noted the raising would let 4DMedical “carry that same momentum into Europe.”
Things moved quickly. March 25 saw the company announce Mayo Clinic’s rollout of CT:VQ on a 90-day starter deal, bringing the number of U.S. academic medical centers on board since FDA clearance last September to six. Before Mayo, the product landed at Stanford, Cleveland Clinic, University of Miami, UC San Diego Health, and University of Chicago Medicine.
Fouras called Mayo’s move a “landmark moment,” adding that the sales pipeline is “never looked stronger.” Yet, according to the filing, the Mayo deal isn’t financially material right now—though the hospital could emerge as an influential reference site. ASX Announcements
The race is heating up. 4DMedical claims its CT:VQ system delivers ventilation-perfusion imaging minus the radiotracers, a move that steps directly into a field previously dominated by nuclear medicine solutions like Cyclopharm’s Technegas. Technegas, a mainstay for ventilation imaging in combination with perfusion scans, has long been the go-to for pulmonary embolism cases.
But a regulatory nod doesn’t equal revenue. Europe still has to come through with hospital contracts and actual clinical uptake. The new funds will boost 4DMedical’s share count by roughly 2.45%. And in the U.S., even one of the big headlines this week — Mayo — kicked off with a 90-day agreement that, by the company’s own admission, isn’t financially material.
Bell Potter Securities took the lead manager and bookrunner roles on the placement. 4DMedical reported a pro forma cash balance of A$289 million as of Dec. 31, adding that some of the fresh funds could be directed toward strategic growth—acquisitions included.
