Brainomix Ventures into the U.S. Market Unveiling its Advanced Stroke AI Platform After Securing a Series of FDA Approvals

Wednesday, November 22, 2023

Brainomix, a leading medtech solutions company driven by AI, is expanding its footprint in the United States by introducing its full suite of FDA-cleared modules within the Brainomix 360 platform, specifically designed for stroke care. This comprehensive platform, inclusive of the previously announced e-ASPECTS module with FDA clearance, aims to assist clinicians in making informed imaging-based treatment decisions throughout the entire stroke pathway. Well-regarded as a market leader in Europe and an innovator in the field of stroke AI solutions, Brainomix is committed to bringing its advanced technology to a wider range of stroke centers in the U.S.

Powered by state-of-the-art AI algorithms, the Brainomix 360 platform offers real-time interpretation of brain scans, aiding clinicians in treatment and transfer decisions for stroke patients. The objective is to ensure that a greater number of patients receive timely and suitable treatment. 

The FDA clearances encompass Brainomix 360 e-CTP and Brainomix 360 e-MRI, two software modules supporting treatment decisions related to thrombolysis and thrombectomy, particularly for late-window patients arriving at the hospital more than 6-12 hours after a stroke. Additionally, Brainomix introduced two new notification tools, Brainomix 360 Triage LVO and Brainomix 360 Triage ICH, offering real-time alerts to clinicians in cases where bleeding or large vessel occlusion (LVO) is suspected. Identifying LVO is critical in determining a patient's eligibility for mechanical thrombectomy.

A notable aspect of this expansion is the FDA clearance of the e-ASPECTS module, Brainomix's flagship software employing patented, explainable AI. This module assesses non-contrast CT scans, automatically generating an ASPECTS score. Importantly, it features a distinctive overlaid heatmap, enhancing the nuanced assessment of each region and contributing to more informed clinical decisions.


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