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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 Medical Device product lifecycle with 24/7 client support

MCRA, the leading privately held independent medical device, diagnostics and biologics Clinical Research Organization (CRO) and advisory 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 product lifecycle.

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

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

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The services provided by MCRA’s AI & Imaging Center focus on the entire medical device study lifecycle, including regulatory support, study design and establishment, data collection & pooling, expert recruitment and training, statistical analysis, performance testing, and project & 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 utilizes well-established zero print, state of the art imaging analysis and data management software with 24/7 support for clients and network specialists.

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Alex Cadotte, Ph.D., Senior Director, Digital Health and Imaging Regulatory Affairs, says “As the only fully integrated AI & Imaging Center, our value lies in the expertise of our team, which includes former FDA experts that understand the regulatory landscape and clinical processes. Our value proposition is ensuring the study is designed and run in a way that meets FDA’s expectations and ultimately decreases time to market by running the right study the first time.”

MCRA is excited to continue advancing imaging and digital health innovation in the medical device industry by helping clients navigate the evolving AI/ML imaging landscape.

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

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Anthony Viscogliosi, CEO of MCRA says “The MCRA AI & Imaging Center truly integrates our deep regulatory experience with clinical study execution, technology and performance testing. This new addition to MCRA will only allow us to improve client success over the entire product lifecycle focusing on the main goal – FDA Approval.”

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