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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 it was selected by an emerging artificial intelligence (AI) company to conduct its pivotal medical device clinical trial. Throughout this trial, Intrinsic Imaging will assess the clinical performance of this novel AI software in detecting musculoskeletal pathology.
Intrinsic Imaging has established itself as 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. This is Intrinsic Imaging’s twelfth AI/DL/CAD MRMC clinical trial award in support of an FDA/EMEA submission.
For this study, Intrinsic Imaging was selected due to its:
- Proven success with multiple FDA clearances of Class I-III AI/DL/CAD software
- Operational excellence and experience conducting large MRMC AI/DL/CAD trials
- Successful FDA Inspection of an MRMC AI/DL/CAD trial with Zero 483 observations
- ISO 13485 certification specifically for providing services for medical devices
- Ability to quickly source large numbers of reviewers using its network of 200+ reviewers
- Ability to effectively and efficiently manage 6,000-20,000 case reviews
“Certified by the British Standards Institute, Intrinsic Imaging provides the most efficient means to assess the clinical performance of AI/DL/CAD software in support of an FDA and EMEA submission,” said Todd A. Joron, BSc. MBA, President & COO, Intrinsic Imaging.