EMVision Medical Devices (ASX:EMV) has received central institutional review board ethics approval for its pivotal validation multicentre diagnostic performance trial of the emu brain scanner in the US.
The company said the review board designated the study as a non-significant risk. This means the study benefits from abbreviated requirements that allow rapid study start-up and accelerated enrolment procedures that expedite its execution.
EMVision said site contracts and administration finalisation are in process, after which the US investigational sites will be named. Australian ethics approval is in process, pending a near-term committee meeting.
The company said the trial, designed to support FDA De Novo clearance, remains on track for activation in March.