July 27, 2016
Intrinsic Imaging Awarded International Clinical Trial to Determine Efficacy of Innovative Class III Medical Device
International trial evaluates a Class III medical device for lower back pain, with imaging review and data management.
Download the PDFBolton, MA / San Antonio, TX — July 27, 2016 — San Antonio (TX), Bolton (MA)
Intrinsic Imaging, an FDA audited, ISO 9001, 13485 and 22301 certified imaging core lab, announced today that it has been awarded a large international clinical trial designed to investigate the efficacy of a Class III medical device designed for the treatment of lower back pain.
With its team of seventy full-time, board-certified, fellowship trained radiologists, Intrinsic Imaging has extensive experience in providing services in support of Class I, Class II and Class III Medical Device Trials and Phase I-IV Clinical Trials across all therapeutic areas and indications.
Intrinsic Imaging’s musculoskeletal team consists of fellowship trained radiologists with specific expertise in the full complement of spine disease processes including musculoskeletal interventions. Intrinsic Imaging also has a wealth of experience in the qualitative evaluation of musculoskeletal diseases utilizing various quantitative assessments criteria systems including examples such as Greulich and Pyle, Kellgren-Lawrence, OARSI, and WORMS.
Throughout this pivotal trial, which includes thousands of radiological reviews acquired using multiple modalities, Intrinsic Imaging will provide comprehensive imaging core lab services including protocol and charter development, radiological review and data management.
“The outcome of this important study will determine if this new treatment option improves upon the current standard of care,” said Todd A. Joron, BSc., MBA, President & COO at Intrinsic Imaging. “Intrinsic Imaging is extremely pleased to be a critical partner in this innovative medical device trial.”
According to the American Spinal Decompression Association, more than 80% of the population is affected by low back pain at some point in their lives. This places a tremendous burden on a patient’s quality of life as well as a financial burden on the entire health care industry.
About Intrinsic Imaging, LLC
Intrinsic Imaging is an ISO certified medical imaging CRO and imaging core lab providing comprehensive services in support of Phase I-IV clinical trials and Class I, II, III medical device trials. Intrinsic Imaging is also a world leader in conducting Artificial Intelligence studies. With its team of more than 650 board-certified and fellowship-trained physicians, Intrinsic Imaging’s team has sub-specialization in all therapeutic areas, including Cardiovascular, Central Nervous System,Gastroenterology, Musculoskeletal, Oncology and Ophthalmology. Certified by the British Standards Institution (BSI), Intrinsic Imaging is the only company in the world to hold five ISO certifications specifically for providing imaging core lab services on clinical trials. For more information, please visit www.IntrinsicImaging.com.
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