“We provide the quickest and most efficient method for Sponsors to assess the clinical performance of their CAD/AI/DL software and obtain FDA clearance.”
Bolton, MA, San Antonio, TX (PRWEB) 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
- 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 our network of 200+ reviewers
- 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.”
Intrinsic Imaging MRMC CAD/AI/DL clinical trials are conducted within Intrinsic Imaging’s ISO Certified quality management system framework. With its portfolio of five ISO certifications certified by the British Standards Institute, Intrinsic Imaging has the most comprehensive and sophisticated quality management system in the industry.
To have Intrinsic Imaging manage your CAD/AI/DL clinical trial, please contact Intrinsic Imaging at
Contact(at)IntrinsicImaging(dot)com or call 1-978-634-2215.
About Intrinsic Imaging, LLC
Intrinsic Imaging is 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. Our team consists of more than 70 full-time, board-certified, fellowship trained radiologists and 100 consulting radiologists and key opinion leaders. Our Team has sub-specialization in all therapeutic areas including Cardiovascular, Metabolic & Pulmonary, Gastrointestinal & Genitourinary, Medical Device, Musculoskeletal, Neuroradiology and Oncology. With our medical expertise, operational excellence and ISO certified quality management system, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world.