Leading Artificial Intelligence Company Selects Intrinsic Imaging to Conduct Pivotal Clinical Trial to Support FDA Submission

BOLTON, Mass. / SAN ANTONIO, Texas — January 11, 2018 — Intrinsic Imaging, a full-service medical imaging core lab providing comprehensive services in support of clinical trials for new drug applications and medical devices, announces today that it has been selected by a leading artificial intelligence company to conduct their pivotal multiple-reader multiple-case (MRMC) clinical trial in support of their upcoming submission to the Food and Drug Administration (FDA).

This is Intrinsic Imaging's fifteenth (15th) clinical trial it has been awarded to assess the clinical performance of artificial intelligence software in detecting pathologies from medical images.

"Intrinsic Imaging is the world leader in conducting multi-reader multi-case (MRMC) trials to assess the clinical performance of medical devices using artificial intelligence (AI), deep learning (DL) and computer assisted detection (CAD) algorithms," said Todd A. Joron, BSc. MBA, President & COO, Intrinsic Imaging. "We provide the most efficient means towards achieving FDA clearance of AI medical devices."

During this new study, Intrinsic Imaging will manage all aspects of the clinical trial including providing all resources to review and quality control over 14,000 radiology reviews.

Intrinsic Imaging was selected due to its proven clinical performance that has led to multiple FDA clearances of AI software, its successful FDA inspection of an MRMC AI clinical trial with zero 483 observations, and its operational excellence and experience conducting large MRMC AI trials.