The mark enables the company to sell the WristView™ hand and wrist MRI system within the European Economic Area (EEA).
The FDA cleared, WristView™ MRI machine is a dedicated hand and wrist MRI system which cuts out the claustrophobic feelings associated with conventional full-body MRI scanner.
The system is safe, requiring no special shielding room or cooling systems, while providing high-quality results that can be easily accessed by doctors across a broad range of fields, in medical facilities which would not normally have the budget or the specialized staff required to operate a full-body MRI scan.
This also comes at a fraction of the price of a conventional whole body MRI. WristView™ is based on a one-tesla permanent magnet, the most powerful permanent magnet in the field, with bore size and general design that are robust and optimized for the application.
In layman’s terms, it takes all of the power and quality of a large, full-sized MRI machine and squeezes it into the smaller, more compact Aspect design.
With the new CE mark, the company will be able to sell to all of Europe, as well as Australia, New Zealand, and Eastern European countries that recognize the CE Marking. The WristView™ may also be sold in some Asian markets since having both the CE and FDA markings is a major advantage, and Asian markings are based on the same principles.
"We are thrilled to bring our MR imaging solutions to a wider international audience," said Uri Rapoport, Founder and CEO of Aspect Imaging.
"Europe makes up a large percentage of the global market for this product in particular, and we’re extremely excited to now have the ability to introduce our system there. We encourage all people suffering from rheumatoid arthritis and carpal tunnel syndrome to demand that their condition be diagnosed with MRI. "
Aspect Imaging is part of Aspect Intl. LLC, a Singapore based company, the world’s leader in the design and development of compact MR imaging and NMR systems for medical, advanced industrial, and preclinical applications.
