Hyperfine AI-Powered Software for MRI Cleared

FDA has cleared a Hyperfine 510(k) for its upgraded Swoop AI-powered software for use with the Swoop Portable MR Imaging System. The software is intended to improve the image quality of the “diffusion-weighting imaging (DWI) sequence with increases in its signal-to-noise ratio,” the company says. “An additional update in this software release increases the Swoop Portable MR Imaging System field of view by 10% for T1, T2, and FLAIR sequences to match the previously improved DWI sequence’s 20cm field of view. Field of view size is important for visualizing pathology deep in the brain.”

The company explains that the improved image quality more clearly displays underlying brain structure to help increase confidence in image interpretation and clinical decision-making. Hyperfine received an initial 510(k) clearance in 2020 for the portable MRI system and two subsequent clearances for hardware improvements and seven clearances for upgraded software.