WASHINGTON, May 9th, 2024/PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is honored to announce its role in propelling innovation in the orthopedic industry through the involvement in more than half of all Orthopedic De Novo's issued by the U.S. Food and Drug Administration.
This impressive record is indicative of the exemplary expertise of MCRA’s renowned team. To date, the US FDA has granted a total of 14 orthopedic De Novo’s, 8 of which were for MCRA clients, including the first ever orthopedic De Novo ever granted back in 2017 for IlluminOss Medical. MCRA continues to provide superb value to clients, from conception to commercialization, and is pleased to have supported more than half of the orthopedic De Novos that have been granted.
Glenn Stiegman, Senior Vice President, Clinical, Quality & Regulatory Affairs, states “MCRA’s Orthopedic team is known worldwide for its exceptional track record and ability to help clients achieve their goals. Our De Novo success record is yet another reason clients trust MCRA with its regulatory needs. We are delighted to be such a top player in the orthopedic medical device industry.”
Anthony Viscogliosi, CEO of MCRA states, “MCRA has long been known for its exceptional work in the orthopedic space. This achievement, led by the exemplary Orthopedic experts at MCRA, shows our ability to work closely with clients and the FDA to bring new orthopedic 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
For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com