EMVision Medical Devices (ASX:EMV) started a validation trial for its first commercial device, the emu bedside brain scanner, to support a De Novo clearance from the US Food and Drug Administration, a filing on the Australian bourse on Thursday showed.
The company secured an Australian ethics approval, and The Royal Melbourne Hospital was greenlit as the first Australian hospital after a successful site initiation visit. Operator training is in progress.
An emu device was shipped to the first US site, the University of Texas Health Science Center at Houston Medical School and Memorial Hermann-Texas Medical Center. A site initiation visit is planned for the coming weeks.
Further trial sites in the US and Australia will be named and activated shortly, per the filing.
The scanner is a non-invasive, non-ionizing device that uses ultra-high frequency radiofrequency scanning technology combined with advanced artificial intelligence-based algorithms to assist in point-of-care stroke diagnosis.
The company's shares gained over 5% in recent trading on Thursday.
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