Aspect Imaging Announces FDA Clearance of M2™ Compact MRI System for Clinical Imaging of the Wrist
Clinical studies on point-of-care wrist imaging planned at UCLA
Using this novel compact MRI platform
SALT LAKE CITY, UT, April 19, 2013 /PRNewswire/ - Aspect Imaging, the world leading developer of compact high-performance magnets, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's M2™ compact MRI system for diagnostic imaging of the wrist. The system is a novel compact, high-performance MRI instrument for rapid, just-in-place imaging of the wrist. Its design encompasses many of the benefits of Aspect Imaging's unique compact MRI design - - affordability, compact design, patient-centric ergonomics, powerful MR-based imaging, and simple, quiet operation. The announcement is being made at the ISMRM (International Society for Magnetic Resonance in Medicine) 21st Annual Meeting, being held April 20 - 26, 2013 in Salt Lake City, Utah.
"The clearance for our M2 compact wrist MRI system by the FDA is an exciting step for Aspect Imaging. Our M2 imaging platform is truly unique in its value proposition to provide a high standard of patient care with a new paradigm of cost-effective MR-based imaging", says Uri Rapoport, Aspect Imaging's Founder and CEO. "We have had significant interest globally from clinicians for our system because of its ease of use, its ease of installation without the need for a specific dedicated facility, and the system's high-quality images and simple workflow. With this FDA clearance, we will begin to provide this system to clinicians interested in diagnostic-quality imaging of the wrist in an affordable, flexible product at a fraction of the cost of existing clinical MRI systems".
The Aspect system, unlike conventional high field MRI systems, does not require a shielded room, cryogens, or high capacity electrical power. The system features an innovative 1 Tesla, self-shielded, permanent magnet operating in a quiet, stress-free manner. As a result, the compact MRI can be placed in most clinical settings as it does not require special infrastructure. This allows siting flexibility for clinicians and providers, with marginal site preparation costs. In addition, patient-centered design and quiet operation combine to enhance patient comfort.
The Company expects to begin commercialization of the instrument in the summer of 2013 and plans to run clinical studies at multiple sites including at the University of California in Los Angeles (UCLA), Department of Orthopaedic Surgery at their facilities at the Ronald Reagan UCLA Medical Center and Santa Monica UCLA Medical Center and Orthopaedic Hospital. The UCLA research studies will be managed by Dr. Kodi Azari, FACS, Surgical Director of the UCLA Hand Transplantation Program and Associate Professor, UCLA Department of Orthopaedic Surgery and Division of Plastic Surgery. A compact MRI system for diagnostic imaging of the wrist will be on display at the ISMRM Exhibition in Aspect Imaging's booth #349 at the Calvin L. Rampton Salt Palace Convention Center in Salt Lake City, Utah from April 21 - 25, 2013.
About Aspect Imaging:
Aspect Imaging (www.aspectimaging.com) is the world's leader in the design and development of high-performance compact MR imaging systems for pre-clinical, clinical and advanced industrial applications. In the clinical market, Aspect Imaging has multiple clinical programs underway including its system to provide highly efficient just-in-place compact MRI for imaging of the wrist. The system allows clinicians to harness the power and insights of MRI but without the cost, complexity and technical burden of traditional MRI systems. In the pre-clinical research market, Aspect supplies its M2™ magnet, gradients and handling systems to Bruker for use in its leading ICON™ compact MRI platform. Due to its high-performance M2 permanent magnet and suite of related products, the ICON enables academic researchers and pharmaceutical companies to harness the power and insights of MRI but without the cost, complexity and technical burden of traditional MRI systems. Pre-clinically, Aspect's M2 system is also used for providing 3D MR-based Histology to complement and direct pathology and histology-based analysis, as well as providing the M2 platform to Mediso Medical Systems for use in its nanoScan® integrated PET/MRI and SPECT/MRI systems. Aspect Imaging's novel permanent magnets are also used in advanced industrial applications including rheology where its MicroFlow™ platform can operate inline on large-scale production lines for food processing, consumer products, biofuels and other applications providing real-time, non-invasive and quantitative read-outs for process and quality control.
SOURCE Aspect Imaging