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).
MCRA announces its role in the successful
granting of Darmiyan's De Novo request for BrainSee by the
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.
John Doucet, Vice President, Neurology Regulatory Affairs –
Neuromodulation and Evolving Technologies at MCRA states, "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. We are proud
to offer this unique combination of talent to help companies like
Darmiyan bring innovative devices to market."
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 & 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 development, review, and granting of the De
Novo request. MCRA is truly unique to have 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. MCRA's level of support spanned the
entire spectrum and included leading our interactions with FDA,
collaborating on development of test protocols, and assistance with
writing the submissions."
About MCRA, LLC: MCRA is the leading privately
held independent medical device, diagnostics, and biologics
Clinical Research Organization (CRO) and advisory firm. MCRA
delivers to its client's industry experience, integrating its seven
business value creators: regulatory, clinical research,
reimbursement, healthcare compliance, quality assurance,
cybersecurity and distribution logistics to provide a dynamic,
market-leading effort from innovation conception to
commercialization. MCRA's integrated application of these key
value-creating initiatives provides unparalleled value for its
clients. MCRA has offices in Washington,
DC, Hartford, CT,
New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo,
Japan and serves nearly 1,000 clients globally. Its core
focus areas of therapeutic experience include orthopedics, spine,
biologics, cardiovascular, diagnostic imaging, wound care,
artificial intelligence, dental, anesthesia, respiratory, ENT,
general surgery, digital health, neurology, robotics, oncology,
general and plastic surgery, urology, and in vitro diagnostic (IVD)
devices. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi
Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in
New York City and specialized in
funding venture capital, private equity, and merchant banking
activities for the neuromusculoskeletal industry. VB is dedicated
to financing healthcare innovation. www.vbllc.com
About Darmiyan: Darmiyan is a pioneering brain technology
(deep-tech) company in San Francisco,
California, focused on developing innovative and rapidly
scalable products for brain health screening and monitoring. The
company's mission is to enhance brain health, equipping physicians
with tools for precise and personalized patient care, thereby
optimizing health outcomes. www.darmiyan.com
For more information, please contact:
Alyssa Howard, Vice President, Business
Development
Phone: 215.870.3952 | Email: ahoward@mcra.com
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SOURCE MCRA, LLC