MCRA Announces Launch of Integrated AI & Imaging Center

Led by former FDA Imaging Experts, MCRA AI & Imaging Center is the first and only integrated solution covering the medical device lifecycle with 24/7 customer support

WASHINGTON , Nov. 27, 2023 /PRNewswire/ — MCRA, the leading private independent Clinical Research Organization (CRO) and medical device, diagnostics and biologics consulting firm, is pleased to announce the launch of its AI & Imaging Center, the first and only integrated solution, led by former FDA imaging experts, covering the entire medical device lifecycle.

MCRA’s AI & Imaging Center is designed to better meet the emerging and complex needs of imaging technologies. By combining innovation, expertise and speed, we accelerate customers’ AI/ML needs faster and more efficiently.

Led by former FDA regulatory and imaging experts, the Integrated AI & Imaging Center provides critical services to medical device customers developing AI/ML-enabled devices and new imaging technologies. The AI ​​& Imaging Center works with an extensive network of radiologists and specialists to provide world-class diagnostic and therapeutic imaging laboratory services.

MCRA’s AI & Imaging Center services address the entire lifecycle of medical device studies, including regulatory support, study design and design, data collection and aggregation, expert recruitment and training, statistical analyses, performance testing, and project and data management . MCRA’s AI & Imaging Center has already provided services ranging from protocol development to study execution and regulatory submissions for more than 50 imaging clients. As a fully integrated solution, MCRA AI & Imaging Center uses proven zero-print, advanced image analysis and data management software with 24/7 support for customers and network specialists.

Alex Cadotte, Ph.D., Senior Director, Digital Health and Imaging Regulatory Affairs, said: “As the only fully integrated AI & Imaging Center, our value lies in the expertise of our team, which consists of former FDA experts who have navigated the regulatory landscape to understand. and clinical processes. Our value proposition is to ensure that the study is designed and conducted in a manner that meets FDA expectations and ultimately reduces time to market by conducting the right study the first time.”

MCRA is excited to continue advancing imaging and digital health innovation in the medical device industry by helping customers navigate the evolving AI/ML imaging landscape. Read more about the MCRA AI & Imaging Center here.

MCRA customer Richie Christian, Head of Regulatory and Quality at Formus Labs says: “The MCRA AI & Imaging Center has provided our technologies with real insights into how the FDA thinks about best practices for AI MedTech. This deep insight allowed us to be more innovative and deliver a best-in-class product to the AI ​​marketplace.”

Anthony Viscogliosi, CEO of MCRA said: “The MCRA AI & Imaging Center truly integrates our deep regulatory experience with clinical trial execution, technology and performance testing. This new addition to MCRA will only allow us to improve our customers’ success throughout the entire product lifecycle, with a focus on the main goal: FDA approval.”

About MCRA, LLC: MCRA is the leading private, independent clinical research organization (CRO) and consulting firm for medical devices, diagnostics and biologics. MCRA delivers its client’s industry experience and integrates its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to deliver a dynamic, market-leading effort from concept of innovation to commercialization . MCRA’s integrated application of these key value-creating initiatives provides unparalleled value to its customers. 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 customers worldwide. Key areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dentistry, 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. Headquartered in New York City, VB specializes in financing venture capital, private equity and investment banking activities for the neuromusculoskeletal industry. VB is committed to financing healthcare innovation. www.vbllc.com

For more information please contact:
Erinn Grable, business development manager
Phone: 202.552.5821 | Email: egrable@mcra.com

SOURCE MCRA, LLC