Brainomix Stroke AI Platform Launched in United States

November 22, 2023—Brainomix, which specializes in the creation of artificial intelligence (AI)–powered software solutions to enable precision medicine for better treatment decisions in stroke, lung fibrosis, and cancer, announced its continued expansion in the United States with the launch of its full suite of FDA-cleared modules in its Brainomix 360 platform, a comprehensive stroke imaging solution.

The United States launch, which includes its previously announced FDA-cleared e-ASPECTS module, introduces a platform designed to support clinicians’ imaging-based treatment decisions at all points across the stroke pathway, from simple imaging to more advanced imaging. The Brainomix 360 e-ASPECTS on a smartphone is an FDA-cleared decision support tool for assessing stroke signs on plain CT brain scans.

According to the company, the Brainomix 360 platform’s AI algorithms provide real-time interpretation of brain scans to aid treatment and transfer decisions for stroke patients. With the platform, the company aims to enable more patients to receive the right treatment, in the right place, at the right time.

The company highlighted the platform at the 2023 Society of Vascular and Interventional Neurology annual meeting held November 16-18 in Miami Beach, Florida. During the meeting, Waleed Brinjikji, MD, delivered a keynote presentation on his experience with the Brainomix 360.

Dr. Brinjikji, who is Professor of Radiology and Neurosurgery at the Mayo Clinic in Rochester, Minnesota, commented in the company’s press release, “We have been collaborating with the Brainomix team around numerous research projects over the past couple of years, including a recent study that validated the performance of their e-ASPECTS module. The results showed that the accuracy of ASPECTS scoring by physicians improved across disciplines and levels of experience, which makes the e-ASPECTS module a powerful tool for clinicians across the United States who are managing stroke patients.”

The company advised that recent FDA clearances include the Brainomix 360 e-CTP (for CT perfusion) and Brainomix 360 e-MRI (for magnetic resonance imaging) software modules that can support thrombolysis and thrombectomy treatment decisions, particularly for late-window patients who present to hospital more than 6-12 hours after stroke onset.

When a large vessel occlusion (LVO) or intracranial hemorrhage (ICH) is suspected, the Brainomix 360 Triage LVO and Brainomix 360 Triage ICH notification tools send real-time alerts to clinicians. The presence of LVO can be a key determinant when deciding a patient's eligibility for mechanical thrombectomy, noted the company.

In March 2023, the company announced the FDA clearance of e-ASPECTS module, its flagship software that is powered by AI to assess noncontrast CT scans to automatically generate an ASPECTS score. It features an overlaid heatmap that enables a more nuanced assessment of each region.

With commercial operations established in the United States, Brainomix will continue to expand as it rolls out products across United States hospital networks.