FDA Clears Hyperfine’s Image-Analysis Software for Portable MR Imaging System

The FDA has granted 510(k) marketing clearance for Hyperfine’s deep-learning image analysis software for use on the company’s Swoop portable magnetic resonance (MR) imaging system.

The software, Advanced AI Applications, is used to measure brain structure and pathology in images gathered by the Swoop system, automatically producing a range of measurements that can indicate a brain injury.

The software is now included in Swoop’s standard software package, taking just minutes after scanning to assess and annotate the brain images.