An announcement from EMvision Medical Devices Ltd. ( (AU:EMV) ) is now available.
EMVision Medical Devices Ltd has commenced a pivotal validation trial for its emu™ bedside brain scanner, aiming to secure FDA De Novo clearance. The trial, involving sites in Australia and the US, seeks to demonstrate the device’s effectiveness in detecting haemorrhages in stroke patients. With an enrolment period of 6-12 months, the trial will enroll 300 participants across six sites, with the goal of achieving a haemorrhage detection sensitivity and specificity of over 80%. This trial is critical for the company’s market positioning as it supports the FDA clearance process and sets the stage for the emu™ device to become a predicate for future products, such as a First Responder device. Concurrently, EMVision is conducting a Continuous Innovation Study to enhance its AI algorithms and device features, further solidifying its competitive edge in stroke diagnostics.
More about EMvision Medical Devices Ltd.
EMVision Medical Devices Ltd is a company operating in the medical device industry, focusing on non-invasive, non-ionising brain scanning technology. Their primary product, the emu™ Brain Scanner, utilizes ultra-high frequency radiofrequency scanning and AI algorithms to assist in stroke diagnosis, with a market focus on point-of-care solutions.
YTD Price Performance: 4.47%
Average Trading Volume: 28,113
Technical Sentiment Signal: Sell
Current Market Cap: A$169.8M
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