Methinks NCCT Stroke
Methinks Software S.L.Methinks NCCT Stroke is an AI-based software designed to assist clinicians by automatically analyzing non-contrast head CT scans to detect signs of intracranial hemorrhage and large vessel occlusion. It prioritizes and notifies suspected positive cases to improve workflow efficiency and triage in stroke care, offering rapid alerts that support clinical decision-making without replacing standard diagnostic procedures.
Intended Use
Methinks NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images to assist hospital networks and trained physicians in workflow triage by flagging and communicating suspected positive findings of intracranial hemorrhage (ICH) and large vessel occlusion (LVO) of the ICA, MCA-M1, and MCA-M2.
Technology
The device uses an AI/ML neural network algorithm to analyze NCCT images in the cloud to detect suspected ICH and LVO and provides notifications through PACS and other clients. It presents preview images meant only for informational notification use, not for primary diagnosis. The device operates in parallel with standard image interpretation workflows and does not alter the original images.
Performance
Performance validation included retrospective, blinded, multicenter, multinational studies confirming high sensitivity and specificity for detecting ICH and LVO on NCCT images. Sensitivities were 94.7% for ICH and 76.4% for LVO with specificities of 99.5% and 91.1% respectively. Time to notification was approximately 1.4 minutes. Reader studies showed the device outperformed expert and non-expert radiologists in LVO detection sensitivity. Cybersecurity risk management and standards compliance were also demonstrated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/6/2025
3 months - 2
FDA Approval
6/16/2025
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