MCRA, a distinguished privately held Clinical Research Organization (CRO) and advisory firm specializing in medical devices, diagnostics, and biologics, is excited to unveil its AI & Imaging Center. This cutting-edge center, led by former FDA imaging experts, marks a unique integrated solution covering the entire lifecycle of Medical Device products. Tailored to meet the intricate demands of emerging imaging technologies, MCRA's AI & Imaging Center blends innovation, expertise, and efficiency to expedite clients' AI/ML needs.

Guided by former FDA regulatory and imaging operations experts, the Integrated AI & Imaging Center offers essential services to medical device clients involved in developing AI/ML-enabled devices and advanced imaging technologies. In collaboration with a diverse network of radiologists and specialists, the AI & Imaging Center provides top-tier diagnostic and therapeutic imaging lab services.

MCRA's AI & Imaging Center extends support throughout the medical device study lifecycle, including regulatory assistance, study design and establishment, data collection and pooling, expert recruitment and training, statistical analysis, performance testing, and project and data management. With a proven track record of servicing over 50 imaging clients, the center has delivered comprehensive solutions, ranging from protocol development to study execution and regulatory submissions. 

As a fully integrated solution, MCRA's AI & Imaging Center employs established zero-print, state-of-the-art imaging analysis, and data management software, complemented by 24/7 support for clients and network specialists. MCRA remains committed to fostering innovation in imaging and digital health within the medical device industry, guiding clients through the dynamic landscape of AI/ML imaging. A satisfied client attests, The MCRA AI & Imaging Center has enriched our technologies with invaluable insights into the FDA's best practices for AI MedTech, allowing us to be more innovative and deliver a best-in-class product to the AI Marketplace.

Source: prnewswire.com