FDA Approves First AI-Powered Alzheimer's Prediction and Diagnostic Test: BrainSee

The FDA has approved Darmiyan's BrainSee, a groundbreaking AI-based diagnostic tool predicting Alzheimer’s dementia progression from amnestic mild cognitive impairment. Utilizing advanced brain imaging and AI, BrainSee offers a non-invasive, accurate prognosis, potentially revolutionizing Alzheimer's management.

Using advanced image processing and medical AI, BrainSee sets a new standard in predicting Alzheimer's from amnestic mild cognitive impairment (aMCI). This significant breakthrough in proactive brain health offers a non-invasive solution for early detection and effective treatment, benefiting millions globally.

Addressing a Global Challenge

With over 100 million people worldwide grappling with aMCI, BrainSee addresses a critical and unmet need. Dr. Padideh Kamali-Zare, Founder and CEO of Darmiyan, envisions BrainSee as a transformative tool in brain health screening and monitoring. She believes it will significantly impact patients and their families by redefining the standards of brain health care.

The Innovation Behind BrainSee

BrainSee, emerging from Darmiyan's technological arsenal, uniquely combines standard clinical brain MRIs with cognitive assessments in a fully-automated platform. Enhanced by advanced whole-brain image analysis and medical AI, it delivers an objective score predicting the progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia within five years, setting a new benchmark in clinical applications.

Implications for Patients and Healthcare

Early screening and risk stratification by BrainSee pave the way for timely and personalized treatments. This is particularly crucial for aMCI patients at high risk of progressing to Alzheimer's dementia. Not only does it aim to delay the onset of dementia, but it also offers reassurance to those at lower risk, potentially reducing the need for more costly and invasive tests.

A Paradigm Shift in Alzheimer's Diagnostics

BrainSee, previously granted FDA breakthrough designation in 2021, represents a paradigm shift in the approach to aMCI workup. Moving away from biomarker-based methods, which often suffer from limitations like invasiveness and high costs, BrainSee offers a non-invasive and actionable forecast of a patient's cognitive trajectory. Its seamless integration into clinical workflows, coupled with the convenience of same-day test results, further enhances its utility.

The global availability of MRI technology enhances the clinical utility of BrainSee, making it a globally accessible tool. Available to physicians via a secure, HIPAA-compliant web portal, BrainSee stands at the forefront of a new era in proactive brain health management.