MCRA Collaborates with Darmiyan to Attain FDA Approval for BrainSee Device

Saturday, May 04, 2024

MCRA, a prominent privately held Clinical Research Organization and advisory firm specializing in medical devices, diagnostics, and biologics, is thrilled to announce its pivotal role in securing FDA approval for Darmiyan's groundbreaking BrainSee through a De Novo request.

Partnering with Darmiyan in 2021, MCRA drew on its extensive expertise in Neurology, Digital Health, and Artificial Intelligence (AI) to navigate the regulatory landscape. The collaboration resulted in obtaining a Breakthrough Device Designation for BrainSee in 2021, followed by the strategic development and submission of a De Novo request in 2022. Following a rigorous review process, the FDA granted approval for BrainSee in January 2024.

BrainSee revolutionizes Alzheimer's diagnostics by combining MRI brain analysis with cognitive test results to generate a predictive score for the progression from mild cognitive impairment (MCI) to Alzheimer's dementia over five years. This innovative medical device marks a significant advancement in the field.

VP of Neurology Regulatory Affairs at MCRA, commends the collaborative effort, stating, "Our close collaboration with Darmiyan was instrumental in achieving both Breakthrough Device Designation and FDA approval for BrainSee.

The synergy between MCRA's Neurology and Digital Health teams was pivotal in developing a comprehensive regulatory strategy tailored to this novel product."

Digital Health and AI at MCRA, emphasizes the importance of multidisciplinary expertise in navigating regulatory pathways, especially as AI applications expand across medical specialties. "Darmiyan's BrainSee demanded a regulatory approach that integrated our expertise in AI, Digital Health, and Neurology. We're grateful for Darmiyan's trust in our ability to secure approval for this transformative product."

Gratitude for MCRA's support throughout the FDA submission process. "Partnering with MCRA was instrumental in achieving FDA approval for BrainSee. Their unparalleled expertise in Neurology, Digital Health, and AI guided us through every step of the journey, from protocol development to FDA interactions."

MCRA's collaborative approach and comprehensive support have been crucial in realizing Darmiyan's vision for BrainSee, underscoring the importance of expert guidance in bringing innovative medical technologies to market.



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