Global developer of compact high-performance magnets Aspect Imaging has obtained clearance from US Food and Drug Administration (FDA) for its M2 compact MRI system, developed for diagnostic imaging of the wrist.
The Canada-based company revealed the development at the ongoing ISMRM (International Society for Magnetic Resonance in Medicine) 21st Annual Meeting in Salt Lake City, Utah.
With FDA clearance in place, Aspect Imaging plans to begin offering the new system to clinicians interested in diagnostic-quality imaging of the wrist at an affordable price.
Claiming that the system would provide high standard of patient care with a new paradigm of cost-effective MR-based imaging, Aspect Imaging founder and CEO Uri Rapoport said the flexible product will be delivered at a fraction of the cost of existing clinical MRI systems.
"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," Rapoport added.
The new instrument comprises an innovative 1 Tesla, self-shielded, permanent magnet, operating in a quiet, stress-free manner - unlike the existing high-field MRI systems that require a shielded room.
Avoiding the need for special infrastructure to place in clinical settings, the compact MRI system allows flexibility for clinicians while improving patient comfort through patient-centered design and quiet operation.
The company plans to start commercialising the device in summer 2013, and commence clinical trials at multiple sites including 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.