EMVision Activates Final Pivotal Trial Site at UCLA, Expands Innovation Study
EMVision Medical Devices is set to activate its sixth and final pivotal trial site at UCLA Health, advancing its emu™ brain scanner towards FDA submission. Meanwhile, the Continuous Innovation Study grows with the addition of Box Hill Hospital.
- UCLA Health site activation completes pivotal trial setup
- Trial Steering Committee formed with global stroke experts
- Recruitment on track for first half 2026 target
- Box Hill Hospital joins Continuous Innovation Study
- emu™ brain scanner aims for FDA De Novo submission
Final Pivotal Trial Site Activation at UCLA Health
EMVision Medical Devices Ltd (ASX, EMV) has announced the imminent activation of its sixth and final site for the pivotal clinical trial of its emu™ brain scanner. UCLA Health, a leading stroke research and treatment centre in the United States, is scheduled to begin patient enrolment within two weeks. This milestone marks the completion of site initiations across four US and two Australian comprehensive stroke centres, positioning EMVision on track to meet its recruitment goals by mid-2026.
A Trial Steering Committee Anchored in Expertise
To oversee the trial’s progress and ensure the generation of robust, decision-grade evidence, EMVision has assembled a Trial Steering Committee comprising internationally renowned stroke specialists. Co-chaired by Professors Geoffrey Donnan and Stephen Davis, both leaders in stroke research and care, the committee includes experts from Harvard, Mount Sinai, and the University of Calgary. Their guidance is expected to enhance the trial’s credibility and support regulatory and commercial milestones.
Recruitment and Study Design
The pivotal trial is designed as a prospective, multicentre, blinded study assessing the diagnostic accuracy of the emu™ brain scanner in detecting intracranial haemorrhages and suspected strokes. With a total enrolment target of 300 participants split evenly between two study arms, the trial leverages high-volume stroke centres to expedite recruitment. The emu™ device’s proximity to radiology bays facilitates seamless integration into patient workflows, enhancing enrolment efficiency.
Expansion of the Continuous Innovation Study
Parallel to the pivotal trial, EMVision’s Continuous Innovation Study is progressing well, now with the addition of Box Hill Hospital in Australia. Recognised internationally for excellence in stroke care, Box Hill joins Princess Alexandra Hospital and John Hunter Hospital in supporting ongoing device development. This study aims to explore additional applications for the emu™ scanner, including potential use in traumatic brain injury assessment, underscoring EMVision’s commitment to continuous product advancement.
Looking Ahead
With the pivotal trial sites fully activated and recruitment underway, EMVision is advancing steadily towards its planned De Novo submission to the U.S. Food and Drug Administration. The company’s CEO, Scott Kirkland, highlighted the significance of collaborating with world-class institutions and experts, expressing confidence in the program’s momentum and future clinical updates.
Bottom Line?
EMVision’s clinical progress and expert oversight set the stage for a critical regulatory milestone in 2026.
Questions in the middle?
- Will recruitment targets be met on schedule across all pivotal trial sites?
- How will interim data shape the timeline for FDA De Novo submission?
- What new capabilities might emerge from the Continuous Innovation Study?
