EMVision Medical Devices (ASX:EMV) has commenced a pivotal clinical trial for its emu™ point-of-care brain scanner, with sites now active in both Australia and the United States.
The trial is designed to support FDA De Novo clearance for EMVision’s first commercial product, which uses radiofrequency scanning and AI algorithms to assist in diagnosing strokes at the bedside. The first Australian site is The Royal Melbourne Hospital, while the first US site is the University of Texas Health Science Center and Memorial Hermann–Texas Medical Center in Houston.
The multicentre validation trial will enrol 300 suspected stroke patients across four US and two Australian hospitals. Its primary goal is to demonstrate that the emu™ scanner can detect haemorrhagic strokes with at least 80% sensitivity and specificity.
“This important milestone marks the culmination of many years of hard work… in pursuit of world-first neurodiagnostic technology,” said CEO Scott Kirkland. He noted that performance in this trial will also inform development of EMVision’s second product, a portable ‘First Responder’ device for use in ambulances and aircraft.
An additional study—the Continuous Innovation Study—will run in parallel at other Australian hospitals, including Princess Alexandra Hospital and John Hunter Hospital, to expand the AI algorithm training dataset and support future product enhancements.
The trial will be conducted with oversight from an independent steering committee and safety board, with data analysis expected following 6–12 months of enrolment.
Shares are trading 7.34% higher at $2.12.
