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
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