Intrinsic Imaging Awarded International Phase II Study for Novel Vascular Medical Device
Bolton (MA), San Antonio (TX) August 21, 2014
Intrinsic Imaging, an FDA audited, ISO 13485 and 9001 certified imaging core lab specializing in providing imaging core lab services for clinical trials, announced today that it has been awarded an international Phase II 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 medical device images.
Intrinsic Imaging is the only ISO 13485 certified imaging core lab specifically certified to provide quality imaging core lab services for medical device clinical trials. The powerful combination of Intrinsic Imaging’s interventional radiology experience with its ISO certified quality management system provides the Sponsor with unprecedented expertise in the management of their medical device clinical trial.
Intrinsic Imaging’s team of full time board-certified, fellowship trained interventional radiologists, are responsible for a broad range of assessments and evaluations of medical devices across the range of therapeutic areas including but not limited to catheters, filters, stents, angioplasty balloons, thrombectomy devices, venous access tools and novel next generation devices.
“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 & Chief Operating Officer, Intrinsic Imaging. “Our team evaluates thousands of medical device images annually, and brings unmatched expertise to Sponsors.”
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.