IMRIS receives FDA clearance for 3 Tesla IMRISneuro

IMRIS Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's 3 Tesla IMRISneuro for sale in the U.S. IMRISneuro is now available with either a 1.5 Tesla (1.5T) or a 3 Tesla (3T) magnet.

Both systems provide IMRIS' patented technology and utilize 70 cm wide bore advanced magnetic resonance imaging systems from Siemens.

The 3T IMRISneuro provides higher quality advanced imaging techniques for surgical planning such as diffusion tensor imaging (DTI), functional MRI and spectroscopy as well as superior quality vascular imaging in a robust platform specifically designed for use in an operating room. This additional system provides hospitals with more choice to meet the unique and growing needs of intraoperative and interventional imaging.

"Just three years after the successful commercialization of our first advanced intraoperative imaging product, IMRIS continues to revolutionize the field with this latest addition of a 3T wide bore magnet to the IMRISneuro family of surgical imaging solutions," said David Graves, President and CEO of IMRIS. "We believe the 3T IMRISneuro system is the most advanced surgical imaging technology available today, providing physicians with timely access to information that can measurably improve the outcome of interventional and surgical procedures."

Mr. Graves continued, "This latest addition to the IMRISneuro platform further demonstrates that IMRIS is at the very leading edge of innovative imaging technology development, and provides another indication of our continuing commitment to improving patient outcomes."

The 3T IMRISneuro has also been approved in Canada, with the first system delivered to Foothills Hospital in Calgary, Alberta in November 2008. Previously, Foothills Hospital led the way in intraoperative MR imaging by being the first in the world to choose the 1.5T IMRISneuro system.