Can EMVision Meet Recruitment Targets to Secure FDA Clearance in 2026?
EMVision Medical Devices reports strong progress in its emu™ Brain Scanner clinical trials, expanding recruitment across seven leading stroke hospitals and introducing new software features to enhance scan quality.
- Seven top-tier stroke hospitals actively recruiting in Pivotal Trial
- New software feature for real-time scan quality feedback under testing
- Additional US hospital sites activated within Mt Sinai and Memorial Hermann networks
- Continuous Innovation Study advancing algorithm and feature development
- Regional Benefits Study funded by $3 million Australian government grant
Clinical Trial Momentum Builds
EMVision Medical Devices Ltd (ASX – EMV) has provided a comprehensive update on the clinical progress of its emu™ point-of-care Brain Scanner, a device designed to improve stroke diagnosis speed and accuracy. The company’s Pivotal (Validation) Trial is now actively recruiting patients across seven world-class stroke hospitals, including renowned institutions such as Mayo Clinic, Mt Sinai, and The Royal Melbourne Hospital.
This trial is a critical step towards securing FDA De Novo clearance, aiming to demonstrate the device’s ability to detect brain haemorrhages with sensitivity and specificity exceeding 80%. With 300 suspected stroke patients targeted for enrolment, the trial’s success will underpin regulatory approval and future commercial adoption.
Expanding Hospital Network and Software Enhancements
EMVision has recently activated additional hospital sites within the Mt Sinai network in New York and the Memorial Hermann network in Houston, broadening access to diverse stroke populations. This expansion is expected to accelerate patient recruitment, following an exponential growth pattern typical of acute stroke device trials.
Alongside recruitment, the company has leveraged insights from early training verification scans to develop a new software feature that provides real-time feedback on scan quality. Currently undergoing in-house testing, this enhancement aims to improve data consistency and clinical workflow integration, further strengthening the trial’s robustness.
Parallel Studies Supporting Innovation and Regional Impact
Running concurrently with the Pivotal Trial is the Continuous Innovation Study, which collects additional training data to refine algorithms and expand device indications. This study is active at several Australian hospitals and supports ongoing device improvements based on real-world clinical data.
Additionally, EMVision has secured a $3 million grant from the Australian Government to conduct a Regional Benefits Study. This project will evaluate the emu™ Brain Scanner’s impact in regional hospitals across South Australia, particularly where access to advanced neuroimaging and specialist care is limited. The study aims to demonstrate tangible benefits in stroke diagnosis timeliness and effectiveness, potentially paving the way for broader telehealth integration.
Looking Ahead
CEO Scott Kirkland emphasised the company’s disciplined approach to trial preparation and data quality, expressing confidence that recruitment targets will be met within the first half of 2026. As the trial progresses, EMVision plans to continue updating the market on enrolment milestones and clinical findings, which will be pivotal for regulatory submissions and commercial strategy.
Bottom Line?
With recruitment accelerating and new features in development, EMVision is poised to make significant strides towards regulatory approval and market entry in 2026.
Questions in the middle?
- How quickly will recruitment accelerate as new hospital sites come online?
- What impact will the new real-time scan quality software have on trial data integrity?
- When can investors expect initial readouts or interim results from the Pivotal Trial?
