Technology | April 22, 2013

Aspect Imaging Receives 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

April 22, 2013 — Aspect Imaging has announced the U.S. Food and Drug Administration (FDA) has cleared the Company's M2 compact magnetic resonance imaging (MRI) system for diagnostic imaging of the wrist. The system is a 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 compact MRI design — affordability, compact design, patient-centric ergonomics, powerful MR-based imaging and simple, quiet operation.

"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,” said Uri Rapoport, Aspect Imaging's founder and CEO. “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 site 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).

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