FDA clearance covers a novel, patented feature that enables physicians to assess ischemic core volume from universally available non-contrast CT (NCCT) images through the 360 Stroke platform. Studied and validated by leading U.S. stroke centers, the new feature demonstrated equivalency to CT perfusion and MRI-derived core volume assessments.
Powered by state-of-the-art AI algorithms, 360 Stroke provides real-time interpretations of brain scans. It aids in the treatment and transfer decisions for stroke patients, according to the company.
Brainomix says its latest feature addresses a longstanding unmet need in stroke triage. It enables physicians across stroke networks to access expert-level insights for decision-making using routinely available brain scans.
The company says its platform represents the only stroke AI imaging tool with a demonstrated impact on treatment rates. A real-world evaluation of the system saw an association with a more than 50% increase in mechanical thrombectomy rates. The company initially won an FDA nod for its stroke imaging platform in 2023.
This latest announcement marks more good news for Brainomix, which recently entered into a high-profile partnership on stroke care. In February, the company partnered with Medtronic to integrate AI solutions into clinical practice.
Dr. Michalis Papadakis, CEO and co-founder at Brainomix, said the expansion “marks a critical advancement in stroke imaging.” Papadakis said it reinforces the company’s mission to transform stroke care with cutting-edge technology.
“Brainomix 360 empowers stroke teams by unlocking real-time, high-precision insights that can help expand patient access to life-changing treatments, including both thrombolysis and mechanical thrombectomy, for use up to 24 hours after stroke onset,” said Dr. Michalis Papadakis, CEO and co-founder at Brainomix.
