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MCRA Supports Darmiyan with FDA Approval for BrainSee Device

WASHINGTON, May 2, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the successful granting of Darmiyan's De Novo request for BrainSee by the U.S. Food and Drug Administration (FDA).

Darmiyan retained MCRA in 2021 for its broad and deep experience in Neurology, Digital Health, and Artificial Intelligence (AI). MCRA’s team of regulatory experts collaborated closely with Darmiyan to achieve a Breakthrough Device Designation for BrainSee in 2021, develop the evidence and strategy for submission of a De Novo request in 2022, and navigate the rigorous FDA review process to secure granting of the De Novo request from FDA in January 2024.

BrainSee’s AI algorithm combines analysis of an indicated patient’s brain MRI with their results on cognitive tests to provide a BrainSee score. The score helps doctors determine the patient’s likelihood of progression from amnestic mild cognitive impairment (MCI) to Alzheimer’s dementia in the next 5 years. BrainSee is a first-of-a-kind medical device and represents a major advancement in Alzheimer’s diagnostics.

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