FDA grants 510(k) clearance to NeuroXT's NEXT-Cue AI medical device
The NEXT-Cue system combines MRI scans with patient data to predict progression to Alzheimer's dementia within five years. The company plans to launch the product in South Korea early next year.
- Field
- medicine and diagnostics
- What they did
- NeuroXT Inc received FDA clearance for its AI software NEXT-Cue, which analyzes brain MRI scans to predict the progression from mild cognitive impairment to Alzheimer's dementia within five years.
- Why it matters
- The approval will help clinicians in US and Korean healthcare institutions better assess disease risk and accelerate the adoption of AI-based diagnostic tools in clinical practice.
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