Intrinsic Imaging Awarded Clinical Study for Novel Neurointerventional Medical Device
Bolton, MA, San Antonio, TX February 12, 2014
Intrinsic Imaging, an FDA audited, ISO 9001 and ISO 13485 certified medical imaging core lab specializing in providing imaging core lab services for clinical trials, announced today that it has been awarded a clinical study for a novel neurointerventional medical device.
Throughout this trial, Intrinsic Imaging will provide comprehensive imaging core lab services including specialized radiologic review by its team of board-certified interventional neuroradiologists.
Neurointerventional medical devices enable sophisticated endovascular procedures within the vessels of the brain to treat stroke and other neurological disorders. This class of medical devices encompass neurothrombectomy devices (suction/aspiration device, clot retriever, and snare device), stenting systems (carotid and intracranial stents including embolic protection systems), aneurysm coiling devices (platinum coils and liquid embolic agents) and a myriad of support devices (microcatheters and microguidewires).
“The increasing prevalence of vascular disorders of the brain and spine has resulted in the development of many neurointerventional devices requiring detailed imaging evaluation,” said Todd A. Joron, BSc. MBA, President & COO, Intrinsic Imaging. “Our team of board-certified, fellowship trained interventional neuroradiologists have extensive training and expertise in the utilization and evaluation of neurointerventional devices.”
Intrinsic Imaging has obtained quality certification for the International Organization for Standardization (ISO) standard for medical devices, ISO 13485:2003. Intrinsic Imaging’s ISO 13485:2003 certification demonstrates the company’s ability to provide imaging core lab services that consistently meet customer and regulatory requirements applicable specifically to medical devices. Intrinsic Imaging medical device certification was granted by the British Standards Institute (BSI), one of the world’s largest certification bodies.
About Intrinsic Imaging LLC
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than sixty board-certified diagnostic 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.