Intrinsic Imaging Awarded Landmark Medical Device Trial for Treatment of Symptomatic Venous Outflow Obstruction
Bolton (MA), San Antonio (TX), July 27, 2015
Intrinsic Imaging, an FDA audited, ISO 9001 and ISO 13485 certified, GAMP® 5 compliant medical imaging core lab specializing in providing services for clinical trials, announced today that it has been awarded a four year clinical trial to study an interventional medical device designed for the treatment of symptomatic venous outflow obstruction.
Intrinsic Imaging will provide comprehensive imaging core lab services for all aspects of this trial which also includes radiological review of over 4000 venogram, x-ray and ultrasound exams by Intrinsic Imaging’s team of full time board certified interventional radiologists.
Intrinsic Imaging is one of the only ISO 13485 certified imaging core lab specifically certified to provide quality imaging core lab services for Medical Device clinical trials. Its certification was granted by the British Standards Institute (BSI), one of the world’s largest certification bodies.
“As an International Imaging Core Lab, Intrinsic Imaging’s team has extensive experience in providing services in support of Medical Device Trials,” said Todd A. Joron, BSc. MBA, President and Chief Operating Officer, Intrinsic Imaging. “Our full-time, board-certified, fellowship-trained interventional radiologists have experience assessing medical devices including, but not limited to, ablation devices, angioplasty balloons, catheters, CAD software, drug delivery devices, filters, stents, thrombectomy devices, venous access tools and wires.”
Intrinsic Imaging has more than sixty full-time, board-certified diagnostic radiologists on staff that have sub-specialization in all therapeutic areas including, Cardiovascular, Central Nervous System, Gastrointestinal & Genitourinary, Medical Device, Musculoskeletal, Oncology and Pulmonary.
Current studies being managed by Intrinsic Imaging range from 4 months to 9 years in duration and are ongoing in 58 countries.
About Intrinsic Imaging, LLC
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001 and ISO 13485 certified, GAMP® 5 compliant medical imaging core lab specializing in providing imaging core lab services for clinical trials. Its comprehensive medical imaging core lab services include, but are not limited to, expert radiologist consultation, protocol and charter development, site qualification, training and management, as well as image acquisition, processing and detailed radiologic analysis.