WASHINGTON, May 20, 2021 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating US and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce the hiring of Fernando Aguel as Vice President, Heart Failure & Circulatory Support Regulatory Affairs. Fernando previously served as U.S. Food and Drug Administration (FDA) Assistant Division Director, Circulatory Support Devices Team. MCRA’s Cardio division continues to expand its expertise across all product areas in the cardiovascular space to provide clients with expert regulatory guidance, clinical study design and clinical trial execution.
Fernando has extensive scientific and regulatory background in the cardiovascular space. In his previous position at the FDA, Fernando led a multidisciplinary staff who reviewed cardiovascular devices including durable and percutaneous ventricular assist devices (VAD), artificial hearts, intra-aortic balloon pumps, cardio-pulmonary bypass and extra-corporeal membrane oxygenation (ECMO) devices, and other devices to treat heart failure and pulmonary hypertension in addition to CPR devices, compressible limb sleeves, auto-transfusion devices, temperature management devices and more. Fernando oversaw the review process for pre-submission, IDE, 510(k), 513(g), and PMA regulatory submissions. Fernando previously served as a biomedical engineer with the FDA in which he evaluated safety and effectiveness of clinical data for various cardiovascular product trials. He also served on numerous strategic committees at the FDA, such as Division of Cardiovascular Devices (DCD), Office of Device Evaluation and Center for Devices and Radiological Health (CDRH) Management, and presented regulatory perspectives at scientific conferences, including TCT, CRT, ELSO and SCAI Shock.
MCRA’s Vice President, Head of Cardiovascular Regulatory Affairs, Michael John, said “Fernando is a high-impact addition to MCRA Cardio, and brings a compelling blend of regulatory expertise and deep scientific knowledge to the team. His nuanced understanding of the regulation of heart failure and circulatory support devices is unparalleled in the field, and he will add tremendous value to clients seeking FDA approval for their devices. Having worked together at the FDA for many years, I am thrilled to again have the opportunity to collaborate with Fernando, and provide best-in-class regulatory counsel to our clients.”
Fernando commented "I am honored to join such a highly competent and experienced team of regulatory and clinical advisors. It is important for companies with new and innovative technologies to carefully consider their regulatory strategy on their path to market. We do that with the unique insight we deliver. I look forward to working with the MCRA team to guide clients in bringing novel cardiovascular products to patients in need.”
About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from concept 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, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices as well as medical device cybersecurity. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specializes 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 visit the company's website at www.mcra.com or contact:
Anne O'Brien
Director, Cardiovascular Business Development
Phone: 708.704.2857
Email: aobrien@mcra.com