Intrinsic Imaging Core Lab Expertise Contributes to FDA Clearance of Medical Device
Bolton, MA, San Antonio, TX (PRWEB) March 20, 2012
Intrinsic Imaging, an ISO 9001:2008 certified and GAMP 5 compliant medical imaging core lab, announces today that its’ expertise has contributed to the U.S. Food and Drug Administration’s (FDA) clearance of a neurointerventional medical device.
During the clinical trial used as basis for FDA clearance of the device, Intrinsic Imaging provided imaging core lab services and its team of board certified neuroradiologists provided the complex interpretation and radiological assessment of the devices primary endpoints.
“Intrinsic Imaging is very proud to have acted as the medical imaging core lab on this clinical trial and that our therapeutic, operational and regulatory expertise has contributed to the FDA’s clearance of this very important neurointerventional medical device.” said Todd A. Joron, BSc., MBA, President and Chief Operating Officer, Intrinsic Imaging.
Neurointerventional medical devices are used for the prevention and treatment of various central nervous system (CNS) diseases and disorders including Alzheimer’s disease, aneurysms, arteriovenous malformations, brain/CNS tumors, epilepsy, head trauma, hydrocephalus, Parkinson’s disease, and stroke.
“Clinical trials involving disorders of the central nervous system often present a number of challenges due to the extensive knowledge base required and due to the complexity of image assessments and interpretations.” said James Dix, MD., Medical Director, Neuroradiology at Intrinsic Imaging. “We are pleased our neuroradiology imaging core lab expertise was able to effectively contribute to the clearance of a very beneficial and effective new treatment for patients.”
Intrinsic Imaging radiologists are deeply involved in the diagnosis and treatment of central nervous system disorders and perform hundreds of thousands of CNS related radiologic reviews annually. Their team of 10 full time board certified neuroradiologists specializes in all brain and spine pathology with broad experience and expertise in MRI, CT, diagnostic and interventional angiographic procedures, as well as PET imaging using novel CNS markers.
About Intrinsic Imaging LLC
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001, ISO 13485, ISO 22301 and ISO 27001 certified and GAMP5 compliant medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than seventy board-certified fellowship trained radiologists, robust and scalable clinical imaging technologies and its ISO certified quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world.