The Food and Drug Administration (FDA) has granted De Novo approval to BrainSee (Darmiyan, San Francisco, California), a first-in-class clinical test for potential use in the evaluation for Alzheimer disease (AD). BrainSee is a software that uses whole brain image analysis and medical artificial intelligence (AI) technology to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to AD within 5 years. The FDA previously granted BrainSee breakthrough designation in 2021.

BrainSee is a noninvasive software that assesses risk for progression to AD using MRI images and cognitive assessments involved in the standard workup for the clinical assessment of patients who are experiencing memory problems. According to a statement from Darmiyan, the application of BrainSee in clinical practice can potentially enable earlier personalized treatment to delay onset of dementia. Additionally, the scores provided are intended to relieve anxiety for patients who are at low risk of progression to AD, preventing further testing that may be unnecessary, costly, and invasive.

"Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way. BrainSee is the first product of this vision, backed by our solid technological infrastructure that is capable of driving further transformations and scalable innovations in the brain health landscape," stated Dr. Padideh Kamali-Zare, Founder and CEO of Darmiyan.