The FDA cleared Aspect Imaging’s compact M2 MRI system for diagnostic wrist imaging, which is designed for in-place wrist imaging without a shielded room.
The clearance was announced at the 21st annual meeting of the International Society for Magnetic Resonance in Medicine in Salt Lake City, Utah, taking place this week.
"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," said CEO Uri Rapoport in prepared remarks.
The company said it will begin distribution this summer and will run additional clinical studies at multiple sites, including at the University of Southern California in Los Angeles, the Dept. of Orthopaedic Surgery at their facilities at the Ronald Reagan UCLA Medical Center and Santa Monica UCLA Medical Center & Orthopaedic Hospital.