EMVision Medical Devices ’s Post
We are pleased to announce that we have commenced the pivotal trial, designed to support FDA De Novo clearance, for our first commercial device, the emu™ bedside brain scanner.The Royal Melbourne Hospital has been greenlit to commence as the first Australian hospital after a successful site initiation visit and with operator training in process. The Royal Melbourne Hospital is a world-class comprehensive stroke centre, and home to the Melbourne Brain Centre - the largest brain research collaboration in the southern hemisphere. We are proud to continue our close collaboration with the team at The Royal Melbourne Hospital, who were instrumental to the success of our prior pre-validation 'EMView' study.In addition, an emu™ device has been shipped to our first US site, University of Texas Health Science Center at Houston (UTHealth) Medical School and Memorial Hermann-Texas Medical Center (TMC). UTHealth Houston has a long tradition of stroke care innovation, having pioneered the use of tissue-type plasminogen activator (tPA), a life saving treatment for acute ischaemic stroke, and mobile stroke units to expedite its delivery. A site initiation visit is planned for the coming weeks.Additional sites will be announced and activated shortly.Read more here https://lnkd.in/g8N4Na8X
Exciting news!
EMVision Medical Devices ’s PostEMVision Medical Devices3,788...
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Thomas Jreige | Risk Management | Global Security, Geopolitics & Digital Counter-Terrorism Expert | Strategic CIO/CISO/CSO & International Relations | BSc, MSc, LLB, LLM, MBA, PhD (Strategic Studies), DipPsych
1hHuge congratulations to the entire team on reaching this incredible milestone!The emu™ bedside brain scanner represents the kind of innovation that has real-world, life-saving impact—and it’s exciting to see such a strong collaboration between world-class centres like The Royal Melbourne Hospital and UTHealth Houston.Pivotal trials are a major step forward, not just for regulatory pathways, but for transforming stroke care at the bedside. Looking forward to watching this journey unfold and seeing the difference this technology will make for patients and clinicians alike.