WASHINGTON, June 26,
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 aiding CamDiab's artificial pancreas software,
CamAPS FX, in achieving U.S. Food and Drug Administration (FDA)
clearance.
CamDiab retained MCRA's team of Digital Health and Quality
Assurance experts to assist with the FDA submission process for the
CamAPS FX app. Due to the nature of the software used, the MCRA
team assembled a pre-determined change control plan (PCCP) to
ensure the software could be updated easily, without the need for
additional FDA submissions. The pre-determined change control plan
is an impressive achievement for MCRA and CamDiab, as it is a
relatively new concept from the FDA with a high-level of expertise
needed.
The CamAPS FX is an advanced adaptive hybrid closed-loop app
that acts as an 'interoperable automated glycaemic controller
device' (iAGC). The Android app – known as the world's first
artificial pancreas app – helps to manage glucose levels in people
with type 1 diabetes, aged two and older, including during
pregnancy. The app allows a compatible insulin pump and a
compatible continuous glucose monitor to 'talk to each other',
creating an artificial pancreas.
Nima Akhlaghi, Director, Digital
Health & Imaging Center Lead at MCRA states, "MCRA's team is
thrilled to have helped support CamDiab's new app for diabetes
treatment, CamAPS FX. Our Digital Health and Quality Assurance
teams worked diligently to provide an avenue to success for this
innovative diabetes app and are proud to have assisted in obtaining
FDA clearance."
Dr. Roman Hovorka at CamDiab
said, "CamDiab is grateful for the invaluable support provided by
MCRA's team in achieving FDA clearance for our innovative diabetes
treatment app, CamAPS FX. The dedication and expertise of MCRA's
Digital Health and Quality Assurance teams were instrumental in our
success, and we appreciate their tireless efforts in paving the way
for this milestone."
Anthony Viscogliosi, CEO of MCRA
states, "MCRA's experts lead the industry in utilizing new and
innovative approaches to secure regulatory success for our clients.
By exploring these new pathways for submissions, our clients are
better able to serve patients around the world."
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 CamDiab: CamDiab Ltd is a digital health and
personalized medicine company focused on the design, development,
and commercialisation of its world leading, interoperable CamAPS FX
closed loop app. The CamAPS FX is designed to use adaptive,
self-learning control algorithm, linked to a compatible
continuous glucose monitoring device and a compatible insulin pump,
to autonomously compute and direct insulin delivery to maintain
desired glycaemic levels. Since its founding in 2019, its mission
has been to help people with type 1 diabetes and their families
live better lives. For further information, visit www.camdiab.com
or follow CamDiab Ltd and its products on Facebook, LinkedIn, and X
(formerly Twitter) @CamAPS_FX.
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