Challenges with Radiologic AI Tools in MedTech
Over the past 10 years, innovation in AI imaging software has exploded, with over 600 cleared FDA submissions. Artificial intelligence and machine learning tools are rapidly transforming radiologic imaging and digital health — but most fail compliance with the necessary regulatory requirements.
MCRA’s Expertise with AI/ML Enabled Medical Devices
MCRA’s AI & Imaging Center helps you run the right study the first time.
Led by former FDA experts and powered by a global network of imaging and clinical professionals, we are the only integrated solution built specifically for AI/ML-enabled medical devices in radiology. Our team partners with you to plan, execute, and manage regulatory-grade studies that generate the evidence your tool needs — not just to function, but to gain market approval.
Whether you're preparing for your first FDA interaction or recovering from gaps in a prior submission, we help you avoid costly mistakes by aligning your clinical evidence with FDA expectations from the start.
Our expertise in the AI and ML enabled devices industry is unique. We provide regulatory guidance by former FDA reviewers in:
- Software as a Medical Device (SaMD)
- Software in a Medical Device (SiMD)
- Study Design and Performance Testing
- AI/ML Enabled Devices
- Computer Aided Devices (CADt, CADe, CADx)
- Medical Imaging
- Quantitative Imaging (Automated and Semi-automated segmentation tools, presurgical planning, smart measurement tools)
Our team provides study and protocol design and review by former FDA experts for standalone, ground truthing, and reader studies. Our expertise covers a wide range of imaging modalities, including but not limited to X-Ray, CT, and MRI across more than 35 therapeutic areas. The AI & Imaging Center supports data collection and data sourcing from US sites for retrospective studies as well.
AI & Imaging Center Services for Radiological AI Tools
Regulatory Support & Strategy
- Regulatory strategy and submission support for AI/ML tools (SaMD, SiMD, CADt, CADe, CADx)
- Navigating regulatory pathways for generative and adaptive AI tools in radiologic workflows
Clinical Study Design & Execution
- Reader study and performance testing design (standalone, ground truthing, and MRMC validation)
- Imaging operations with clinical-grade quality controls
- Data sourcing and management from U.S. imaging sites
- Statistical analysis and FDA-level reporting
Expert Network
- Access to hundreds of U.S.-based, board-certified and fellowship-trained radiologists and subspecialists for high-quality reader studies and ground truth adjudication.
Our Team
Meet the MCRA AI & Imaging Center team, comprised of former FDA regulatory, clinical affairs, and imaging services experts.
