FDA Clears AI Software Tool for Automated Detection of LVOs from CT Angiography
The Food and Drug Administration has granted 510(k) clearance to Methinks CT Angiography (CTA) Stroke (Methinks Software, Barcelona, Spain), an artificial intelligence–driven software that detects large vessel occlusions (LVOs) using CTA scans. According to a statement from the company, Methinks CTA Stroke demonstrated high sensitivity and specificity in detecting LVOs while also including distal occlusions up to the middle cerebral artery (MCA)-M2 segment. The approval follows the earlier clearance of Methinks Non-Contrast CT (NCCT) Stroke in July 2025, a device which identifies suspected LVOs and intracranial hemorrhages using NCCT scans.
In their statement, Methinks Software noted that the new CTA-based tool expands the company’s stroke triage platform, enabling comprehensive assessment across both non-contrast and contrast-enhanced CT imaging. Methinks CTA Stroke is intended to be integrated directly into hospital workflows to allow stroke teams to review and share images in real time and potentially accelerate treatment decisions.
Key details about Methinks CTA Stroke:
- Detects proximal (ICA, MCA-M1) and distal (MCA-M2) LVOs.
- Achieved 98.2% sensitivity and 91.6% specificity in validation testing, as reported by Methinks Software.
- Enables real-time collaboration through existing communication platforms.
Source: Methinks Software. Methinks AI secures second FDA clearance, expanding its stroke detection solution to contrast imaging. Methinks. Published October 9, 2025. Accessed October 28, 2025. https://www.methinks.ai/releases/methinks-ai-secures-second-fda-clearance-expanding-its-stroke-detection-solution-to-contrast-imaging