Medical device and MedTech insights, news, tips and more

NOUS Imaging Receives 510(k) Clearance from FDA for Real Time MRI Software

September 25, 2020


NOUS Imaging, a medical imaging software company, today 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 1/10th of a millimetter and enables the MRI scanner operator to control for motion that cannot be sensed by the patient.

See Full Press Release at the Source: NOUS Imaging Receives 510(k) Clearance from FDA for FIRMM Software – FIRMM by NOUS Imaging

Press Release by: NOUS Imaging

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.