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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.
#alzheimer's#fda#ai#mri#diagnostics#neuroxt

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