Brainomix 360 e-CTA 14.2

The Brainomix 360 e-CTA software is designed to automate the analysis of CT angiography (CTA) images to detect large vessel occlusions (LVOs), which are critical blockages often found in stroke patients. It also standardizes the assessment of collateral vessels—blood vessels that can bypass blocked arteries—using color heat-map visualization to aid clinicians in evaluating blood flow alternatives. This helps streamline decision-making for time-sensitive interventions like thrombectomy.

The Brainomix 360 e-CTA is supplied as a software package, meaning it is not a physical device but rather an application that integrates with existing medical imaging systems. It operates on standard clinical imaging platforms used for CTA scans, allowing trained professionals to run the automated analysis directly within their workflow. No additional hardware is required beyond a compatible imaging system.

The Brainomix 360 e-CTA is explicitly designed as a non-reusable software tool, meaning it is intended for repeated use across multiple patients within a clinical setting. Since it is a software-based solution and not a physical implant or consumable, sterility is not applicable. The device is also non-sterile, as it does not come into direct contact with patients or sterile environments.

The Brainomix 360 e-CTA has undergone regulatory review through FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU. These pathways confirm its classification as a Class IIb device, which requires rigorous validation for automated diagnostic software. The device adheres to these standards to ensure its safety, performance, and clinical utility in detecting LVOs and collateral vessels.

As a software-based medical device, the Brainomix 360 e-CTA does not have physical storage requirements like temperature control or humidity constraints. However, it must be installed on a secure, compliant medical imaging system with regular software updates to maintain functionality and regulatory compliance. The manufacturer’s guidelines should be followed for system maintenance, including backup procedures and access controls, to ensure uninterrupted performance in clinical settings.