EMVision Prepares to Add Acute Ischemia Detection Endpoint to Brain Scanner Validation Trial; Shares Up 8%
EMVision Medical Devices (ASX:EMV) is advancing preparations to add an acute ischemia detection endpoint to its pivotal validation trial for its point-of-care brain scanning device, with US Food and Drug Administration (FDA) meeting and protocol amendment planned, according to a Wednesday Australian bourse filing.The trial is a multi-center, prospective, blinded diagnostic performance study designed to support US FDA De Novo clearance for its emu brain scanner product, per the filing. The primary objective of the trial is to demonstrate hemorrhage detection sensitivity and specificity of greater than 80%.A first responder aeromedical feasibility and usability study for its pre-hospital brain scanning device with Royal Flying Doctor Service was completed during the June quarter, the filing said.The company's shares rose past 8% in recent trading on Wednesday.
