Helping AI Developers Navigate the Complex Path to Market

WCG Imaging is a full-service central imaging core lab providing comprehensive, customized artificial intelligence clinical trials. We conduct stand-alone and multi-case multi-reader observer (MRMC) performance studies to evaluate AI and computer-assisted detection systems.

WCG Imaging provides the expert guidance you need to meet aggressive timelines, reduce costs and increase the likelihood of FDA clearance.

The most FDA clearances of AI/CAD/Viewer devices in the industry


imaging centers supported in 75 countries


board-certified, fellowship-trained physicians

Leverage a Trusted and Experienced Guide to AI Clinical Trials

If you’re developing AI technology for the life sciences, innovation is just the beginning. You now need to bring your technology to market.

The FDA regulatory path is complex, and it can be challenging for those unfamiliar with the process. Before your trial begins, you must clear several hurdles, including:

  1. Develop explicit, auditable AI validation protocols
  2. Create a study plan and a data-collection protocol
  3. Source cases that adequately represent the target indication and therapeutic area
  4. Secure institutional review board (IRB) approval

It’s a daunting process. You need a partner who anticipates the challenges that lie ahead and helps you overcome them. This is where WCG Imaging can help.

How WCG Imaging Supports You

Your needs, our expertise:

We adapt to meet your unique needs delivering the optimum combination of resources based on your timing and budget requirements. We’ll adjust as your needs change.

A partner, not a vendor:

A dedicated WCG team will stay with you the entire journey, working alongside you to bring your innovative technologies to the patients who need them. We listen. We respond. We are always available.

Why Choose WCG Imaging? Because Expertise Matters.

Since 2010, WCG has conducted the most multi-reader, multi-case (MRMC) AI trials across all therapeutic areas and indications.

As the world leader in AI core lab imaging services and AI validation trials, WCG has the most FDA clearances of AI/CAD/Viewer devices in the industry.


Deep expertise in all therapeutic areas and modalities with unmatched trial speed and quality

Report Approval

Multiple successful FDA inspections with zero 483 observations

Search Report

30,000+ expedited case reviews

ISO Certified Quality Management System

WCG Imaging is the only imaging core lab to hold five ISO quality management system certifications specifically for imaging core lab services in clinical trials: ISO 9001, ISO 13485, ISO 22301, ISO 27001, and ISO 27018.

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Ready to Start Your Path Toward FDA Clearance? Contact Us.

We have the team, therapeutic expertise, and ISO-certified quality management systems you need for your AI trial.

Complete this form to connect with one of our experts. During the call we’ll share:

  • 8 Lessons Learned for Completing AI Studies On Time
  • Checklist for Conducting AI Studies
  • 3 Crucial Mistakes to Avoid when Developing AI Clinical Programs