Intrinsic Imaging Awarded Its Tenth Clinical Trial for Computer Aided Detection (CAD) / Artificial Intelligence (AI) / Deep Learning (DL) Software

Bolton, MA / San Antonio, TX — August 15, 2017 — Intrinsic Imaging, a full-service medical imaging core lab providing comprehensive services in support of Phase I-IV clinical trials and Class I, II, III medical device trials, announces today the award of another multiple-reader multiple-case (MRMC) study to assess the clinical performance of computer aided detection (CAD) / Artificial Intelligence (AI) / Deep Learning (DL) software.

This is Intrinsic Imaging's Tenth (10th) MRMC clinical trial award to evaluate CAD/AI/DL software in support of an FDA submission.

Intrinsic Imaging was selected due to its operational excellence and experience conducting large MRMC CAD/AI/DL trials; successful FDA inspection of an MRMC CAD/AI/DL trial with zero 483 observations; proven success with multiple FDA clearances of Class I-III CAD/AI/DL software; ISO 13485 certification specifically for providing services for medical device clinical trials; ability to quickly source 15–30 reviewers using its network of 200+ reviewers; and ability to effectively and efficiently manage 6,000–20,000 case reviews.

"Intrinsic Imaging is the world leader in conducting multi-reader multi-case CAD/AI/DL studies," said Todd A. Joron, BSc. MBA, President & COO, Intrinsic Imaging. "We provide the most efficient means to assess the clinical performance of CAD/AI/DL software in support of an FDA submission."