FDA’s De Novo approval of BrainSee represents a major advancement in Alzheimer’s diagnostics. Utilizing cutting-edge image processing and medical AI, BrainSee establishes a new standard for predicting progression from amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia. This breakthrough is a significant step in proactive brain health management, offering a fully non-invasive, convenient, and globally accessible screening solution, to be prioritized before other tests or treatments.
SAN FRANCISCO, Jan. 12, 2024 /PRNewswire/ — Today marks a turning point in the battle against Alzheimer’s disease as Darmiyan, Inc., a leading company in brain health innovation announces the FDA’s approval of its first-in-class (De Novo) clinical test, BrainSee. This approval marks a pivotal advancement in brain health and opens the door to untapped market potential in brain disease diagnosis and management.