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March 3, 2015 - Boston, MA, San Antonio, TX - Intrinsic Imaging, an FDA audited, ISO 9001:2008 and ISO 13485:2003certified, GAMP® 5 compliant medical imaging core lab specializing in providing services for clinical trials, announced today that it has been awarded a clinical trial to study an interventional medical device designed for the prevention of pulmonary emboli.
Throughout this trial, Intrinsic Imaging will provide comprehensive imaging core lab services including, but not limited to, protocol and charter development, site qualification, site training and management, image transfer, blinding and processing as well as the specialized radiologic review of images.
Intrinsic Imaging is the only imaging core lab that is ISO 13485 certified specifically to provide quality services for medical device clinical trials. The company’s team of full-time, board-certified, fellowship-trained interventional radiologists have experience assessing medical devices including, but not limited to, catheters, stents, angioplasty balloons, thrombectomy devices, venous access tools, novel devices and biologics.
Importantly, in addition to device assessment, Intrinsic Imaging is able to guide in the development of the imaging charter and provide expertise in the selection of imaging modalities and acquisition protocols that are best oriented towards the placement, assessment and evaluation of medical devices.
“We are pleased to have been chosen to apply our medical device expertise to this trial,” said Todd A. Joron, BSc. MBA, President and Chief Operating Officer, Intrinsic Imaging. “Acute pulmonary emboli are the most serious clinical presentation of venous thromboembolic disease and a major cause of hospitalization, morbidity and mortality. Intrinsic Imaging brings Sponsors unprecedented expertise in the management of medical device clinical trials.”
Intrinsic Imaging’s medical device certification was granted by the British Standards Institute (BSI), one of the world’s largest certification bodies.