Intrinsic Imaging Awarded Genitourinary Medical Device Clinical Trial
Bolton (MA), San Antonio (TX), August 12, 2014
Intrinsic Imaging, LLC, an FDA audited, ISO 13485 and ISO 9001 certified medical imaging core lab specializing in providing imaging core lab services for clinical trials, announced today that the company has been awarded a clinical trial for the evaluation of a Genitourinary Medical Device for the treatment of urinary incontinence.
Intrinsic Imaging’s full time team of more than sixty board-certified diagnostic radiologists have sub-specialization in all therapeutic areas including, but not limited to Genitourinary, Cardiovascular, Central Nervous System, Gastrointestinal, Medical Device, Musculoskeletal, Respiratory and Oncology.
Intrinsic Imaging’s team of board certified, fellowship trained 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.
Throughout this trial, Intrinsic Imaging will use its expertise in evaluating medical devices to provide comprehensive medical imaging core lab services as well as the specialized radiologic review of genitourinary pelvic floor images captured using dynamic MRI.
“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,” said Todd A. Joron, BSc. MBA, President and Chief Operating Officer, Intrinsic Imaging. “When you couple our interventional radiology experience with our ISO certified quality management system, Intrinsic Imaging is able to provide Sponsors with unprecedented expertise in the management of their medical device clinical trial.”
Intrinsic Imaging’s medical device certification was granted by the British Standards Institute (BSI), one of the world’s largest certification bodies. Intrinsic Imaging’s ISO 13485 certification demonstrates Intrinsic Imaging’s ability to provide quality imaging core lab services that consistently meet customer and regulatory requirements applicable specifically to medical devices.
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.