FDA clears text

FDA Clears NOUS Imaging’s MRI Motion-Monitoring Software

September 24, 2020

St. Louis-based NOUS Imaging has received 510(k) clearance to market its Framewise Integrated Real-Time MRI Monitoring (FIRMM) software for calculating patient motion during magnetic resonance imaging (MRI) head scans.

The software is used as an add-on to MRI scanners to measure motion during image acquisition, so the motion can be suppressed. The monitoring does not require a separate camera or other sensing technology.

The latest software version, FIRMM 5, includes metrics on the image quality and an improved user interface. NOUS Imaging expects to launch the product by the end of 2020.

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