Aspect Imaging Announces FDA Clearance of M2(TM) Compact MRI System for Clinical Imaging of the Wrist

Salt Lake City (ots/PRNewswire) -

- Clinical studies on point-of-care wrist imaging planned at UCLA

- Using this novel compact MRI platform

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(TM) 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 [http://www.ismrm.org/13 ], 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 (http://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
[http://www.aspectimaging.com/clinical/product/wrist-mri-system ],
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(TM) magnet, gradients and
handling systems to Bruker for use in its leading ICON(TM) compact
MRI platform
[http://www.aspectimaging.com/pre-clinical/product/bruker-icon ]. 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 [http://www.aspectimaging.com/pre-clinical/product
/m2-3d-mr-based-histology-system ] 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(R)
[http://www.aspectimaging.com/pre-clinical/product/mediso-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(TM)
[http://www.aspectimaging.com/advanced-industrial/products ] 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.

For further information:

Robert Sandler
SVP, Marketing
Aspect Imaging
T. +1-416-274-8166
E. rsandler@aspectimaging.com

ots Originaltext: Aspect Imaging
Im Internet recherchierbar: http://www.presseportal.de