EMVision advances bedside brain scanner trials across two continents

Medical device company EMVision announced on Tuesday that five of its six pivotal trial sites are now actively enrolling and scanning patients for its bedside brain scanner, marking a significant milestone in the company’s quest to revolutionise stroke diagnosis.

The Sydney-based company’s emu bedside brain scanner is being tested across leading hospitals in the United States and Australia as part of a pivotal validation trial designed to support FDA approval for the portable device.

The site initiation visit and device training at Mount Sinai in New York has been completed successfully, with recruitment now underway. The final sixth site for the pivotal validation trial is expected to be announced shortly, having recently cleared their local institutional review board.

The trial aims to enrol up to 300 suspected stroke patients across four sites in the US and two sites in Australia over an estimated period of six to 12 months. All trial sites are high-volume comprehensive stroke centres.

EMVision has also received approval to commence its Continuous Innovation Study for stroke and traumatic brain injury patients at Princess Alexandra Hospital in Brisbane and John Hunter Hospital in Newcastle. Both sites are high-volume comprehensive stroke and level one trauma centres.

The emu device uses non-ionising radiation and is designed to improve neurodiagnostic access through its ease of use and portability. The technology could potentially allow medical teams to quickly assess brain injuries at the bedside without the need for traditional CT or MRI scans.

Once approved, the emu device is anticipated to become the predicate device for EMVision’s second commercial product, the First Responder device, which would target the pre-hospital market including ambulance and aeromedical services.

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