BrainSee Software Receives FDA Approval for Whole Brain Image Analysis

BrainSee (Darmiyan, San Francisco, California) has received De Novo approval from the Food and Drug Administration (FDA) to utilize their first-in-class clinical test for the possible assessment of Alzheimer disease (AD). BrainSee is software that predicts the probability of amnestic mild cognitive impairment (aMCI) developing into Alzheimer's disease (AD) within five years using whole brain image analysis and medical artificial intelligence (AI) technologies. In 2021, the FDA had already designated BrainSee as a breakthrough.

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, as per practicalneurology.

Furthermore, the ratings supplied are meant to reduce worry for individuals who are at low risk of developing Alzheimer's disease, avoiding unneeded, costly, and invasive testing.

"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.