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# FDA Clears InMed.AI NeuroShield Tool
- URL: https://www.fdaweb.com/fda-clears-inmed-ai-neuroshield-tool/
- Published: 2023-11-13T12:00:00.000Z
- Updated: 2026-09-14T14:15:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155777

FDA has cleared an InMed.AI 510(k) for NeuroShield, which the company describes as an automated brain geometry-based quantifying analytics tool that uses “AI/Deep Net/3D Convolutional Networks to support physicians as a clinical decision support tool for neurologists and neuroradiologists.”

NeuroShield takes 3D magnetic resonance images as inputs and automatically calculates brain volumes to assist physicians in configuring treatment plans for patients with neurodegenerative diseases such as dementia, Alzheimer’s, Parkinson's, and epilepsy, InMed says. The clearance is based on data from a U.S.-based trial involving 280 subjects that demonstrated the product’s accuracy across scanners of different magnetic strengths, clinical subgroups, gender, age, slice thickness, and geographic regions, it says, adding that the “segmentation analysis revealed remarkable accuracy, reliability, and effectiveness of NeuroShield.”