JLK's Stroke AI 'JLK-NCCT' Receives FDA Approval

Screening Suspected LVO Patients with NCCT
Expanded Analysis Range Covering ICA, M1, and M2

JLK, a medical artificial intelligence (AI) company, has received approval from the U.S. Food and Drug Administration (FDA) for its non-contrast CT-based stroke analysis solution.

Product operation image of JLK Artificial Intelligence Solution 'JLK-NCCT'. JLK

On March 26, JLK announced that 'JLK-NCCT' has received FDA 510(k) clearance.

This solution is capable of detecting intracranial hemorrhage using non-contrast CT (NCCT) images and identifying patients suspected of large vessel occlusion (LVO). It is designed to enable the detection of LVO, which is typically evaluated using CT angiography (CTA), during the initial screening stage.

In performance evaluations, the solution achieved a sensitivity of 78.5% and a specificity of 90.3%, surpassing the results of radiology specialists (sensitivity of 56.8% and specificity of 84.0%). Another notable feature is the expanded analysis range, which includes not only the internal carotid artery (ICA) and the M1 segment of the middle cerebral artery, but also the peripheral M2 segment.

Non-contrast CT is the first imaging test performed in most stroke patients. The company plans to leverage this product to secure patient triage capabilities at the early diagnostic stage and to expand its AI-based workflow into subsequent diagnostic and treatment steps such as CTA and MRI.

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