FDA clears Aspect's M2 compact MRI system for diagnostic imaging of wrist

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) 21^st 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.