AI-Powered Alzheimer’s Diagnosis Accelerator Receives De Novo OK

An AI-powered product from Darmiyan that detects potential early stages of Alzheimer’s has received an FDA De Novo clearance.

BrainSee, previously granted the agency’s breakthrough designation in 2021, is designed to assist physicians treating patients with amnestic mild cognitive impairment (aMCI) in accelerating diagnoses of Alzheimer’s dementia.

The product uses AI algorithms to study brain MRI results and generates a score predicting the likelihood of a patient’s progression to Alzheimer’s within five years. San Francisco-based Darmiyan expects BrainSee to reduce both the emotional and financial hardships of aMCI patients with a lower risk of progression. Physicians can now access the platform through a secure web portal.

To read the whole story, click here to subscribe.

Related Topics