Aspect Imaging Announces FDA Clearance of M2 Compact MRI System for Clinical Imaging of the Wrist
4/19/2013 7:35:41 AM
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