RadiSpine Receives TFDA Class II Medical Device Approval for Lumbar MRI Analysis

RadiSpine receives TFDA Class II authorization

RadiSpine Receives TFDA Class II Medical Device Approval

RadiSpine, registered in Taiwan as the RadiRad Spine Magnetic Resonance Imaging Artificial Intelligence Quantification System, has received Class II medical device approval from the Taiwan Food and Drug Administration (TFDA). The Taiwan medical device manufacturing license number is 008564. This marks an important step in bringing the team's medical imaging AI into clinical use.

Integrating Lumbar MRI Analysis into Clinical Workflows

RadiSpine focuses on lumbar MRI analysis, using automated segmentation and quantitative information to support healthcare professionals in image assessment. The team will continue refining the user experience around clinical workflows so that AI analysis can be incorporated into professional interpretation and reporting.

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