Over the past 10 years, innovation in AI imaging software has exploded, with over 600 cleared FDA submissions. MCRA is at the cusp of this exciting change in healthcare. MCRA’s deep therapy specialization and heritage of clinical and regulatory leadership is best positioned to offer these key services as this exciting time period unfolds.

Artificial Intelligence and Machine Learning use in radiologic imaging and Digital Health markets for medical devices has grown rapidly over the past decade. The most important consideration when developing an AI-based medical imaging solution is compliance with regulatory requirements. MCRA’s AI & Imaging Center is the only integrated solution led by former FDA staff that harmonizes deep regulatory and clinical expertise to cover the entire MedTech study lifecycle. Our goal is your success by doing the right study the first time.

Our AI & Imaging Center is unique because it incorporates a multidisciplinary team of experts to support the performance assessment of your innovative medical technology by providing the following services:

  • Regulatory Support
  • Clinical Study Design and Execution
  • Data Collection and Sourcing
  • Imaging Operations utilizing our large network of experts and remote Technology Operations.
  • Project and Data Management
  • Statistical Analysis 

MCRA AI & Imaging Center Expertise 

Our multidisciplinary leadership team is comprised of former FDA regulatory, clinical affairs, and imaging services experts. In addition, our team works with an extensive network of experts with a variety of specialties, such as radiology, dedicated to ensuring clients receive quality service and world-class therapeutic imaging lab services. Our experts utilize cutting-edge, well-established software to provide efficient services to clients.

Our expertise in the AI and ML enabled devices industry is unique. We provide regulatory assessment 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. 

Contact an AI & Imaging Center Expert

MCRA AI & Imaging Center Services 

  • Regulatory Services

    MCRA’s regulatory team specializes in more than 35 therapeutic areas, including Imaging and Digital Health. 

    • Study Design and Protocol Development
    • End Point Establishment 
    • Data Assessment 
    • FDA Interactions 
  • Clinical Services

    MCRA’s full service CRO team offers comprehensive clinical support, including:

    • Site Selection and Management 
    • Image Charter Development 
    • Image Acquisition Protocol 
    • Trial Requirements including IRB Establishment 
    • Data Sourcing
  • Imaging Operations

    MCRA multidisciplinary team offering an end-to-end imaging operation solution by providing:

    • Protocol and Report Development
    • Expert Reviewer Selection and Training
    • Software configuration, access and support
    • Data handling and Project Management
    • Statistical Analysis Establishment
    • Study Execution

Our Team

Meet the MCRA AI & Imaging Center team, comprised of former FDA regulatory, clinical affairs, and imaging services experts.

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Alex Cadotte

Alex Cadotte, Ph.D.

Vice President, Digital Health, AI, and Radiology Regulatory Affairs
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Nima Akhlaghi, Ph.D.

Nima Akhlaghi, Ph.D.

Director, Digital Health & Imaging Center Lead
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Gretchen Nelson

Gretchen Nelson

Director, Clinical Affairs
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Chava Zibman, Ph.D.

Chava Zibman, Ph.D.

Principal Statistician- Diagnostics