Class III Medical Device
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
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001, 13485 and 22301 certified, medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than sixty-five board-certified fellowship trained radiologists, robust and scalable clinical imaging technologies and our ISO certified and registered quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world.