FDA Grants De Novo Clearance to Darmiyan’s BrainSee AI Program for Alzheimer’s Risk Prediction

The U.S. Food and Drug Administration (FDA) has issued a de novo clearance for BrainSee, an artificial intelligence (AI) program developed by Darmiyan. This groundbreaking software has the capability to analyze standard brain MRI scans and predict the likelihood of a patient progressing from mild cognitive impairment to Alzheimer's disease and dementia within a five-year timeframe.

Described as a virtual microscope, the BrainSee prognostic program stands out for its potential application as a prelude to positron emission tomography (PET) scans, eliminating the need for radioactive tracer injections. Additionally, it could serve as an alternative to invasive procedures such as biopsies of cerebrospinal fluid, providing a non-invasive and efficient method for assessing cognitive health.

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Darmiyan, a San Francisco-based company founded in 2016, envisions BrainSee as a tool to redefine brain health screening and monitoring standards. The CEO and founder, Padideh Kamali-Zare, expressed the company's vision to make a meaningful impact on patients and their families by revolutionizing the approach to brain health assessment.

BrainSee, having received a breakthrough designation from the FDA in 2021, provides a quantitative score ranging from 0 to 100. This scoring system enables healthcare professionals to categorize patients by risk, aiding in the consideration of appropriate treatment options. Notably, the program requires only a standard 3D MRI scan, without the need for contrast injections, and utilizes cognitive test scores typically collected during diagnostic workups.

The significance of BrainSee lies in its potential to enhance early detection and prediction of Alzheimer's disease, a condition with profound implications for patient care and management. The non-invasive nature of the program aligns with a patient-centric approach to diagnostics, minimizing the need for invasive procedures and radioactive tracers.

Darmiyan's journey to this milestone includes a breakthrough designation in 2021, emphasizing the program's innovative capabilities. The company, which received funding from Y Combinator in 2017, secured a $6 million seed financing round in 2020 led by Eisai, an Alzheimer's-focused drugmaker. Additional support came from IT-Farm and Y Combinator, highlighting the industry's recognition of the company's potential to advance brain health diagnostics.

As BrainSee progresses with FDA de novo clearance, it opens new possibilities for the integration of AI in neurological assessments, contributing to a more streamlined and effective approach in predicting and managing cognitive health issues. The software's approval signifies a step forward in the intersection of AI and healthcare, showcasing the potential for innovative technologies to reshape the landscape of disease diagnosis and patient care.