Intrinsic Imaging Awarded Multi-Center Study for a Novel Vascular Medical Device
Bolton, MA, San Antonio, TX August 13, 2013
Intrinsic Imaging, an FDA audited, ISO 9001 and ISO 13485 certified imaging core lab specializing in providing imaging core lab services for clinical trials, announced today that it has been awarded a multi-center study for a novel vascular medical device. Throughout this trial, Intrinsic Imaging will provide comprehensive imaging core lab services including specialized radiologic review and analysis of all images.
Intrinsic Imaging’s medical device team is led by full time board-certified fellowship trained interventional radiologists all of whom have experience with numerous medical devices in a variety of therapeutic areas, including but not limited to Cardiovascular, Central Nervous System, GI & Genitourinary, Musculoskeletal and Oncology.
Intrinsic Imaging’s team has extensive experience in conducting clinical trials focused on the placement, usage, assessment and evaluation of vascular medical devices including catheters, stents, angioplasty balloons, thrombectomy devices, venous access tools as well as novel devices and biologics.
“Intrinsic Imaging has broad experience in radiography (CR and DR), CT, MRI, ultrasound, and 3D reconstruction techniques as they apply to the deployment and surveillance of medical devices,” said Amit Mehta, MD, FRCP, Chief Medical Officer, Intrinsic Imaging. “Our combined clinical expertise in utilizing novel medical devices and our in-depth experience in clinical trials bring an unparalleled synergy to sponsors in medical device development.”
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.
“The increasing prevalence of vascular diseases and disorders worldwide has resulted in the development of many vascular medical devices requiring detailed imaging evaluation.” said Todd A. Joron, BSc. MBA, President & COO, Intrinsic Imaging. “Our team of board-certified fellowship trained radiologists routinely evaluate thousands of medical device related images annually.”
About Intrinsic Imaging LLC
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001:2008 certified and 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, its robust and scalable clinical imaging technologies and its ISO certified and registered quality management system, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world.