MCRA Expands Digital Health Division

     Alex Cadotte, PhD, Former U.S. Food & Drug Administration (FDA) Team Lead for Imaging Software and Division Lead for Software and Digital Health joins MCRA as Associate Director, Software & Digital Health.


WASHINGTON, May 18, 2021 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce Alex Cadotte, PhD, Former U.S. Food and Drug Administration (FDA) Team Lead for Imaging Software, has joined MCRA. Dr. Cadotte is a published author, award recipient, and central figure in the regulation of digital health and imaging devices at FDA with 15 years of engineering, clinical, and regulatory experience. He was also a member of the CDRH Artificial Intelligence/Machine Learning (AI/ML) Working Group where he was a contributor to the recent AI/ML Action Plan and Predetermined Change Control Plan development.    

Dr. Cadotte joined MCRA, LLC as Associate Director of Software and Digital Health. Prior to joining MCRA, Dr. Cadotte served in multiple key roles in the digital health arena at FDA, including Division Lead, Software and Digital Health, and Senior Lead Reviewer in the Mammography, Ultrasound and Imaging Software Branch.  In addition to Dr. Cadotte’s vast experience in digital health, he also brings valuable expertise in artificial intelligence and machine learning, Computer Aided Detection / Diagnosis / Triage, Quantitative Imaging, the pre-certification program, Real World Performance, Good Machine Learning Practices, software lifecycle processes, cybersecurity, and mobile medical applications.

He has extensive knowledge of FDA’s Total Product Life Cycle, having provided oversight of 510(k), De Novo, Pre-Submission and Pre-Market Authorization (PMA) submissions. His post-market authorization experience includes response and drafting of warning letters and inspection reports.

MCRA’s Director, Digital Health Regulatory Affairs, Nikki Batista, said, “Digital Health is a rapidly growing and complex area of innovation, and navigating the pathway to market requires intentional, efficient, and sound strategic thinking and tactical implementation. The MCRA Digital Health team is committed to providing clients with first-class service, and we are thrilled that Alex has joined our team and will play an instrumental role in supporting clients developing industry shifting technology.”

Dr. Cadotte said “It’s an amazing time to be working in digital health. FDA’s Digital Health Center of Excellence is focused on new and least burdensome means of regulating digital health technology. Understanding how your devices fit into this shifting paradigm can be critical for product development and regulatory success.  I’m honored to work with all of MCRA’s service divisions to streamline medical device development from a total product lifecycle perspective.”.

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.

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. 

For more information, please contact:

Alyssa Howard

Senior Director, Business Development

Phone: 215.870.3952