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

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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.

BOLTON, Mass., SAN ANTONIO, Texas (PRWEB) 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
  • Successful FDA Inspection of an MRMC AI clinical trial with zero 483 observations
  • Operational excellence and experience conducting large MRMC AI trials
  • ISO 13485 certification specifically for providing services for medical device clinical trials
  • Ability to quickly source 15-30 reviewers using our network of 300+ reviewers
  • Ability to effectively and efficiently manage 6,000-20,000 case reviews

Intrinsic Imaging holds five ISO certifications specifically for providing imaging core lab services on clinical trials. 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 artificial intelligence, deep learning or computer assisted detection clinical trial, please contact Intrinsic Imaging at Contact(at)IntrinsicImaging.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 80 full-time, board-certified, fellowship trained radiologists and 224 consulting radiologists and key opinion leaders. Our tTeam 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.

For the original version on PRWeb visit: http://www.prweb.com/releases/2018/01/prweb15080625.htm


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