EMVision Medical Devices Says Eight Hospitals Recruiting For Validation Trial
MT Newswires Live
Apr 13
EMVision Medical Devices (ASX:EMV) said eight hospitals are actively recruiting and ramping up, expanding trial capacity and supporting increased patient screening activity for its validation trial, according to a Monday Australian bourse filing.
The trial is a blinded diagnostic performance study to support the US Food and Drug Administration De Novo clearance for EMVision's emu point-of-care brain scanner product.
No device-related adverse events have been reported, it said.
It also said the emu Regional Benefits study is advancing through preparations ahead of launch in the second half, with a second grant payment of AU$400,000 received during the quarter.
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