Nous Imaging receives 510(k) clearance from FDA for FIRMM software

NOUS Imaging, a medical imaging software company, has announced that the FDA has cleared its 510(k) submission for FIRMM, Framewise Integrated Real-Time MRI Monitoring. FIRMM provides real-time monitoring and biofeedback that addresses the significant problem of patient motion during brain MRI. This is the Company’s first FDA clearance and represents the initial piece of a larger software platform designed to deliver next-generation imaging enhancements for MRI.

FIRMM is a software accessory to an MRI scanner used to calculate and display patient motion during a head scan. The motion results are derived from the MR image data as it is being acquired.  MR images can be imported during the scan and analyzed to detect patient motion in real-time, providing the operator and patient with a tool for motion suppression.  The latest version, FIRMM 5 enhances the user interface, provides image quality and remaining scan-time metrics and integrates patient biofeedback.

“This important milestone puts NOUS in a position to launch FIRMM 5 by the end of this year,” said Ken Bruener, President and CEO of NOUS Imaging.  “FDA clearance validates the data we have collected with our research software over the past two years, and we are excited to offer a commercial version to our leading academic collaborators as well as hospitals and imaging centers throughout the US.”

Damien Fair, PA-C, PhD, Director of the Masonic Institute of the Developing Brain, and Professor of Pediatrics and the Institute of Child Development at the University of Minnesota and Nico Dosenbach, MD, PhD, Associate Professor of Neurology and Radiology at Washington University School of Medicine founded NOUS Imaging and developed FIRMM to reduce the effect of motion on MRI scans. The software-only solution uses MR images directly and does not require a camera or other sensing hardware to be installed on the scanner.  In addition, FIRMM measures and displays movements of less than 1/10^th of a millimetter and enables the MRI scanner operator to control for motion that cannot be sensed by the patient.