Methinks CTA Stroke

“Methinks CTA Stroke is a software-only device which is intended to be used by trained physicians involved in the management of Acute Stroke (AS) patients at emergency settings or other departments across the stroke care pyramid model.”

“Methinks CTA Stroke uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation.”

“Cybersecurity has been integrated into the design and development of the Methinks CTA Stroke device in accordance with FDA's cybersecurity guidance and Section 524B of the FD&C Act. The device underwent rigorous non-clinical testing under clinically relevant conditions. Design verification and validation per 21 CFR Part 820.30 confirmed that all design requirements and specifications were met. Methinks employed a risk-based cybersecurity strategy that includes secure design principles, threat modeling, vulnerability assessment, third-party penetration testing and a Software Bill of Materials (SBOM). Key security controls such as authentication, authorization, secure update mechanisms, and system logging have been implemented. Cybersecurity was addressed as part of the software verification process. Controls including authentication, authorization, cryptography, code, data and execution integrity, confidentiality, monitoring, resiliency and recovery, software updates, patch management, and coordinated vulnerability disclosure are in place to ensure ongoing safety, effectiveness and resilience against cybersecurity threats throughout the device lifecycle.”