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ASX:EMV

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Asia

EMVision Medical Devices Completes First In-Field Feasibility Study of First Responder Brain Scanner

EMVision Medical Devices (ASX:EMV) completed the first in-field feasibility study of its First Responder brain scanner, in collaboration with the Melbourne Mobile Stroke Unit, Australia's first mobile stroke unit, operating out of the Royal Melbourne Hospital, according to a Wednesday Australian bourse filing.The company said that primary usability and workflow objectives were achieved during the first deployment of its portable device in a road-vehicle setting.The company added that it has received an Industry Growth Program (IGP) progress payment of AU$650,437, while a memorandum of understanding has been signed with the Australian Stroke Alliance to pursue research and translational funding for pre-hospital stroke diagnosis.

ASX:EMV
Asia

EMVision Says Brain Scanner Clinical Study in South Australia to Show Ability to Provide Timely Stroke Diagnosis

EMVision Medical Devices (ASX:EMV) said a clinical study in South Australian regional hospitals will be conducted with its emu bedside brain scanner to demonstrate the ability to provide more timely stroke diagnosis, according to a Thursday Australian bourse filing.The study will be conducted under a project funded by the Australian Government's Cooperative Research Centres Projects (CRC-P). A CRC-P progress payment of AU$337,425 was received in August.The study targets regional and remote hospitals without ready on site-computed tomography access.Site visits were completed, and protocol and ethics preparation are well advanced. Next steps include protocol finalisation, ethics approval, site contracting, and research governance approvals.Its shares were up 1% in recent trading on Thursday.

ASX:EMV
Asia

EMVision Medical Devices Says Recruitment for Brain Scanner Validation Trial Surpasses 200 Patients

EMVision Medical Devices (ASX:EMV) said recruitment for its pivotal validation trial for its point-of-care emu brain scanning device surpassed 200 patients across the training and primary analysis groups, according to a Monday Australian bourse filing.The emu device was incorporated into "code stroke" workflows at participating hospitals, and no device-related adverse events had been reported to date, the company said. The company is also adding additional US academic medical centers to the trial, expanding recruitment capacity.The primary objective of the trial is to demonstrate hemorrhage detection sensitivity and specificity of greater than 80%.The medical device company's shares added about 2% in recent Monday trade.

ASX:EMV
Asia

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.

ASX:EMV
Asia

EMVision Medical Devices Secures AU$1.2 Million IGP Grant After First Responder Milestone

EMVision Medical Devices (ASX:EMV) has confirmed that it has met the required progress under its first responder program, triggering the next grant instalment of AU$1.2 million from the Australian Government's industry growth program (IGP), which is expected to be received in May, according to a Monday filing with the Australian bourse.The funding forms part of a AU$5 million non-dilutive grant awarded in June 2025 to support the commercialization of its first responder brain scanner, a portable device intended for pre-hospital use in emergency road and aeromedical settings, per the filing.Payments are disbursed quarterly in advance, subject to eligible spending and milestone delivery, with the company having received AU$1 million so far and AU$2.8 million remaining under the grant facility, the filing added.

ASX:EMV
Asia

EMVision Medical Devices Says Eight Hospitals Recruiting For Validation Trial

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.

ASX:EMV

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