EMVision Medical Devices (ASX:EMV) has secured central Institutional Review Board ethics approval for its multi-center trial of the EMVision emu brain scanner in the US, according to a Wednesday filing with the Australian bourse.
The trial, designated non-significant risk (NSR), allows for a faster start-up and enrollment process, the filing said.
Site contracts are being finalized, with US investigational sites to be named soon, the filing added.
Australian ethics approval is pending while the trial is on track for March activation to support the US Food and Drug Administration's De Novo clearance, per the filing.
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