WASHINGTON, June 18,
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 U.S. Food and Drug Administration's (FDA)
510(k) clearance for 3D Systems' 3D-printed, patient-specific
cranial implant solution — VSP® PEEK Cranial Implant.
3D Systems engaged MCRA for regulatory support with their FDA
submission for VSP PEEK Cranial Implant. MCRA's best in class
biocompatibility team worked with 3D Systems to design and execute
a biocompatibility strategy, including chemical characterization
studies, that addressed FDA expectations and demonstrated that the
device is biocompatible for patient use. The VSP PEEK Cranial
Implant is now the world's first patient-specific and 3D-printed
PEEK cranial implant using an extrusion platform to receive such
clearance.
Eric Sussman, PhD, Director, Biocompatibility at MCRA
states, "MCRA's biocompatibility team was thrilled to be a part of
this critical project for 3D Systems. Our integral experience in
both biocompatibility and with the FDA allowed us to quickly
produce a response to ensure this device received 510(k)
clearance."
Ashley Dawson, PhD, Director,
Regulatory Affairs at 3D Systems said, "This achievement reflects
our commitment to advancing patient care through innovative
solutions. Our successful partnership with MCRA was crucial in
navigating the regulatory process, particularly with their expert
guidance on biocompatibility. Working with MCRA has been a highly
professional and productive experience, and their support was
instrumental in achieving this important milestone."
Anthony Viscogliosi, CEO of MCRA
states, "MCRA's renowned biocompatibility team provided
exceptional work to bring 3D Systems device to market. This
achievement shows MCRA's expertise provides an invaluable service
to our clients and aids in bringing key innovations to the
healthcare industry."
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 3D Systems: More than 35 years ago, 3D Systems
brought the innovation of 3D printing to the manufacturing
industry. Today, as the leading additive manufacturing solutions
partner, we bring innovation, performance, and reliability to every
interaction - empowering our customers to create products and
business models never before possible. Thanks to our unique
offering of hardware, software, materials, and services, each
application-specific solution is powered by the expertise of our
application engineers who collaborate with customers to transform
how they deliver their products and services. 3D Systems' solutions
address a variety of advanced applications in healthcare and
industrial markets such as medical and dental, aerospace &
defense, automotive, and durable goods. More information on the
company is available at www.3dsystems.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