FDA Approves BrainSee, an AI Software That Purportedly Predicts Alzheimers Disease

When a person comes to their doctor with memory problems, they often want to know if AD is to blame, and if so, what they can expect. Answering these questions with any degree of certainty is a tall order, and many view amyloid-PET scans and fluid biomarkers as the best options, when available. However, subtle signs of atrophy lurking within routine MRI scans might also foretell AD—and artificial intelligence might help pick them out. On January 12, the FDA approved BrainSee, an AI-driven software platform that uses MRI data, along with scores from routine cognitive tests, to predict the likelihood that a person with mild cognitive impairment will descend into AD dementia within five years. Developed by San Francisco-based Darmiyan, BrainSee purportedly detects subtle brain shrinkage patterns that correlate with future AD. The approval follows BrainSee’s 2021 breakthrough designation granted by the FDA.

BrainSee costs $1,500, but Vejdani told Alzforum that Darmiyan offers it for $300, pending Medicare coverage. Medicare already covers the cost of the scans themselves, which have an average price tag of $1,000 for those paying out of pocket. Vejdani foresees BrainSee as an initial screening test. Patients with a low probability of dementia can focus on other possible explanations for their cognitive issues, while those with a high probability of AD can seek further testing and treatment.


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Darmiyan-BrainSee-Brochure-Nov-2020.pdf (620.2 KB)