EMVision’s Stroke Scanner Faces Critical Trial and Regulatory Milestones Ahead

Clinical Trial Expansion and Momentum

EMVision Medical Devices has made significant strides in its pivotal validation trial for the emu™ brain scanner, a portable neurodiagnostic device aimed at improving acute stroke care. The trial now includes six leading hospitals across the US and Australia, notably adding UCLA Health to its roster, which broadens access to one of the largest stroke patient populations in America. Additional sites within the Mount Sinai and UTHealth networks are also being activated, underscoring the company’s commitment to robust clinical evidence generation ahead of regulatory submissions.

Operational learnings from the training verification phase have reinforced the trial’s design, with recruitment expected to accelerate and meet targets in the first half of 2026. Independent oversight is provided by a Trial Steering Committee featuring global stroke experts, ensuring the trial’s integrity and the credibility of its data for future FDA approval.

Innovation and Parallel Studies

Alongside the pivotal trial, EMVision’s Continuous Innovation Study is advancing algorithm development and device features, laying groundwork for expanding diagnostic indications such as traumatic brain injury. This parallel study leverages real-world data from hospitals in Brisbane, Newcastle, and Victoria, providing valuable clinical feedback to refine the technology and workflow integration.

First Responder Program Progress

The company’s First Responder device, designed for pre-hospital stroke diagnosis, has achieved key milestones including ethics approvals for studies with the Royal Flying Doctor Service and Melbourne’s Mobile Stroke Unit. The Mobile Stroke Unit study has commenced recruitment, marking a transition from engineering development to operational field evaluation. These studies will inform final device production and commercial readiness, with data collection paired alongside prehospital CT scans to validate performance in emergency settings.

Funding and Financial Position

EMVision successfully raised $12 million through a placement supported by institutional and sophisticated investors, complemented by an oversubscribed Share Purchase Plan expected to bring in an additional $2 million. The company’s cash reserves stood at $18.35 million at quarter-end, bolstered by $7.4 million in available non-dilutive grant funding and an impending R&D tax incentive rebate. Operating cash outflows for the quarter were $3.487 million, reflecting increased research and development and staff costs aligned with clinical and commercial progress.

Notably, EMVision was awarded a $3 million Cooperative Research Centres Projects grant to evaluate the impact of a telehealth-integrated emu™ device in regional hospitals, aiming to reduce stroke diagnosis times and improve outcomes in underserved areas. This grant aligns with government priorities for equitable healthcare access and underscores the societal relevance of EMVision’s technology.

Industry Recognition and Outlook

The emu™ and First Responder devices have garnered prestigious design awards, including the Red Dot and Australian Good Design Awards, validating their innovation and user-centric design. EMVision continues to engage with the global medical community through presentations at major conferences such as the World Stroke Congress and EMS World Expo, enhancing its profile among clinicians and emergency medical professionals.

Looking ahead, the company plans to accelerate patient recruitment, advance pre-hospital studies, participate in key industry events like MEDICA in Düsseldorf, and prepare for regulatory submissions and commercial launch activities. Maintaining financial discipline while executing these strategic milestones will be critical to de-risking the pathway to market.