MCRA, the privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm has announced its role in the successful granting of Darmiyan's De Novo request for BrainSee by the US 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 the 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.

John Doucet, Vice President, Neurology Regulatory Affairs – Neuromodulation and Evolving Technologies at MCRA said, "We are proud to have worked closely with Darmiyan to achieve both Breakthrough Device Designation and marketing authorization from the FDA for BrainSee. Working with Darmiyan was a great example of expert collaboration between MCRA's Neurology and Digital Health regulatory teams. Both groups contributed significantly from the very beginning of our collaboration with Darmiyan. Together we developed an integrated strategy that merged our understanding of the science, regulations, and policy needed to obtain FDA marketing authorization for such a novel and important product."

Alex Cadotte, Vice President, Digital Health, Artificial Intelligence, and Radiology at MCRA said, "As the use of AI in medical technology increases and spreads from Radiology to Neurology and other clinical specialties, it is vital to have a diverse and collaborative team of subject matter experts as you navigate through the FDA. Darmiyan's BrainSee software platform required a regulatory strategy that merged MCRA's scientific and regulatory expertise in AI, Digital Health, and Neurology. We thank Darmiyan for trusting us to help secure the approval for this important new product."

Kaveh Vejdani, Co-founder, Chief Medical and Technology Officer at Darmiyan said, "Darmiyan feels extremely fortunate to have partnered with MCRA to support our successful FDA submissions. The FDA Breakthrough Device Designation for BrainSee was a critical foundation for FDA collaborations during the development, review, and granting of the De Novo request." 

Vejdani also stated that MCRA is truly unique in having world-class scientific and regulatory expertise in Neurology, Digital Health, and AI that are needed to guide novel and ground-breaking devices like BrainSee through the FDA review process.