Artificial Intelligence

Artificial Intelligence Division Highlights

  • Intrinsic Imaging is the world leader in conducting stand-alone and multi-case multi-reader observer performance studies to evaluate Artificial Intelligence (AI) / CAD / Viewer software.
  • Experience and expertise conducting 55 large MRMC AI/CAD trials.
  • Ex. Bone, Brain, Breast, Liver, Lung, Prostate, Liver, and others.
  • FDA registered facility.
  • Successful FDA Inspection specifically for an MRMC AI/CAD/Viewer trial with zero 483 observations.
  • Routinely manages 10,000–30,000 case reviews with expedited timelines.
  • Multiple FDA clearances of AI/CAD/Viewer devices – most in the industry.
  • Unique expertise and significant competitive advantage.
  • ISO 13485 certification specifically for providing services for medical device clinical trials.
AI software analyzing medical images with segmentation overlays on a radiology workstation

Validating an AI/CAD/Viewer device? Our team can help.

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