EMVision (ASX:EMV) Pivotal Stroke Imaging Trial Passes 230 Patients

Sonal Goyal

26 October 2026 03:01 PM AEDT

EMVision (ASX:EMV) Pivotal Stroke Imaging Trial Passes 230 Patients

Image Source: Shutterstock

You are reading a free article with opinions that may differ from the recommendation given by Kalkine in its paid research reports. Become a Kalkine member today to get access to our research reports, in-depth technical and fundamental research. Learn more

Start Your Free Trial Now!

Key Highlights

The Pivotal trial surpassed 230 patients by early October.
The primary analysis target is 300 participants.
A feature to detect acute ischaemic stroke will be validated within the trial.
Stage 1 of the First Responder study met its objectives.

EMVision Medical Devices Ltd (ASX:EMV) released its Appendix 4C and quarterly activities report for the period ended 30 September 2026 on 26 October 2026.

Pivotal trial

By early October the Pivotal (Validation) trial surpassed 230 patients across training and primary analysis cohorts, with most contributing toward the 300-participant primary analysis target.

New feature

EMVision is adding a feature to its emu device to detect acute ischaemic stroke. The company has defined its function and required accuracy and will validate it in the existing trial using data already being collected. It will seek FDA feedback on the approach in the coming months, and if successful emu would offer the capability from its first FDA-cleared release.

Clinical engagement

Mayo Clinic Florida presented early clinical experience with emu at a stroke review, highlighting compatibility with a busy emergency department. Stage 1 of the First Responder Mobile Stroke Unit Study met its usability and workflow objectives, adding to an earlier Royal Flying Doctor Service study.

Company and clinical program

EMVision is an Australian medical technology company developing portable, non-ionising brain scanners: the bedside emu device and an ultra-lightweight pre-hospital First Responder device. The first indication is acute stroke, with traumatic brain injury as a second planned indication, and the company said diagnosis today requires hospital-based CT or MRI. The emu pivotal study supports an FDA De Novo clearance, with acute ischaemia detection added to the protocol and FDA engagement targeted for late calendar 2026 or early 2027.

Why This Could Matter

Trial enrolment relative to the 300-participant target indicates how far the pivotal study has progressed toward its analysis.

Summing Up

EMVision (ASX:EMV) reported over 230 pivotal-trial patients and a planned stroke detection feature.

FAQs

Q: How many patients are in the trial?

A: More than 230 by early October.

Q: What is the target?

A: 300 for the primary analysis.

Q: What feature is planned?

A: Detection of acute ischaemic stroke.

Q: Who presented clinical experience?

A: Mayo Clinic Florida.

Download Free Report – Explore 3 Stock Ideas & Industry Insights

Unlock 3 stock ideas and key industry insights in our free report. This information is general in nature and does not consider your personal objectives, financial situation, or needs. It is not financial advice.

All investments involve risk—consider independent advice before making any investment decisions.

View 3 Research Reports

Disclaimer:

This article (“Article”) has been prepared by Kalkine Pty Limited (ABN 34 154 808 312) (Australian financial services licence number 425376) (“Kalkine”) and its related bodies corporate who are authorised to provide general financial product advice. Kalkine.com.au and its associated pages are published by Kalkine.

Any information/advice provided in this article is general in nature and does not take into account your objectives, financial situation or needs. You should therefore consider whether the information is appropriate for your objectives, financial situation and needs before acting upon it.

There may be a Product Disclosure Statement, Information Memorandum or other offer document (“Offer Document”) for the securities or other financial products referred to in Kalkine articles. You should obtain a copy of the Offer Document and consider it before making any decision about whether to acquire the security or financial product.

Kalkine strongly recommends that you seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice) before acting on any advice/information in this Article or on the Kalkine website. Not all investments are appropriate for all people.

The information in this Article and on Kalkine website has been prepared from a wide variety of sources, which Kalkine, to the best of its knowledge and belief, considers accurate. Kalkine has made every effort to ensure the reliability of the information contained in its articles (including this Article), newsletters and websites. All information represents our views at the date of publication and may change without notice.

The information in this Article does not constitute an offer to sell securities or other financial products or a solicitation of an offer to buy securities or other financial products.

Kalkine does not issue, sell or deal in any financial products.

This Article may contain information on past performance of particular investments. Please note past performance is neither an indicator nor a guarantee of future performance.

To the extent permitted by law, and excluding any dishonesty or gross negligence by Kalkine, Kalkine disclaims and excludes all liability for any direct, indirect, implied, punitive, special, incidental or other consequential loss or damage arising from the use of or reliance on this Article, the Kalkine website and any information published on the Kalkine website without any warranties or representations by Kalkine to you. To the extent the law prohibits or limits this exclusion, Kalkine limits its liability to the resupply of services.

Please also read our Terms & Conditions and Financial Services Guide for further information.

Employees and/or associates of Kalkine and its related entities may hold interests in the securities or other financial products covered in this Article or on the Kalkine website. Any such employees and associates are required to comply with certain safeguards, procedures and disclosures as required by law.

Some of the images/music that may be used in the Article are copyright to their respective owner(s). Kalkine does not claim ownership of any of the pictures displayed/music used in the Article unless stated otherwise. The images/music that may be used in the Article are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated or was found to be necessary.

Kalkine Media Pty Ltd, an affiliate of Kalkine Pty Ltd, may have received, or be entitled to receive, financial consideration in connection with providing information about certain entity(s) covered on its website.