Global developer of compact high-performance magnets Aspect Imaging has obtained clearance from US FDA for its M2 compact MRI system, developed for diagnostic imaging of the wrist.
Canada-based Aspect Imaging revealed the news of its FDA approval at the ISMRM (International Society for Magnetic Resonance in Medicine) 21st Annual Meeting in Salt Lake City, Utah.
Claiming that the system would provide high standard of patient care with a new paradigm of cost-effective MR-based imaging, the company claims its flexible product will be delivered at a fraction of the cost of existing clinical MRI systems.
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.
“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 Aspect CEO and founder Uri Rapoport.
He added; “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.”
Source: Aspect Imaging, medicaldevice-network.com