Artificial Intelligence Division — AI & CAD Validation Studies

Intrinsic Imaging's Artificial Intelligence Division is a world leader in the independent clinical validation of artificial intelligence (AI), computer-aided detection (CAD), computer-aided diagnosis, and advanced medical imaging software. With experience conducting 55 large multi-reader multi-case (MRMC) AI/CAD studies, Intrinsic Imaging brings together deep expertise in medical imaging, clinical trial methodology, physician reader studies, medical device research, and regulatory-compliant study execution. Our experience spans AI technologies developed to detect, characterize, quantify, segment, and assist in the interpretation of disease across a broad range of anatomies and imaging applications, including the brain, breast, liver, lung, prostate, musculoskeletal system, and other clinical areas. Supported by a global network of more than 1,000 board-certified and fellowship-trained physicians, Intrinsic Imaging can assemble highly specialized reader panels matched to the clinical indication, imaging modality, intended use, and regulatory objectives of each AI technology.

The Artificial Intelligence Division provides comprehensive support from study design through final regulatory-ready data delivery, including protocol and statistical design collaboration, case selection and dataset development, ground-truth and reference-standard establishment, reader recruitment and qualification, image and data quality control, reading-environment configuration, reader training, blinded MRMC execution, adjudication, and management of large-scale observer-performance datasets. Intrinsic Imaging routinely manages studies involving 10,000–30,000 individual case reviews and has supported multiple AI/CAD/Viewer technologies that have achieved FDA clearance. Importantly, Intrinsic Imaging has successfully undergone an FDA inspection specifically involving an MRMC AI/CAD/Viewer clinical trial with zero Form FDA 483 observations and maintains ISO 13485 certification for medical device clinical trials. By integrating sophisticated MRMC methodology, extensive subspecialty physician expertise, scalable clinical trial infrastructure, and a rigorous quality and regulatory framework, Intrinsic Imaging provides AI developers and medical device manufacturers with the independent clinical evidence required to objectively demonstrate the safety, effectiveness, and clinical performance of next-generation medical imaging technologies.