Hyperfine Software Cleared for Improved Brain Imaging

The FDA has granted clearance to Hyperfine’s upgraded artificial intelligence-based software which provides improved brain imaging for its Swoop portable magnetic resonance imaging (MRI) device.

The upgraded software increases the signal-to-noise ratio — so that the signal is greater than the noise, which improves image quality.

Other upgrades include a 10 percent increase in the size of the field of view as field size “is important for visualizing pathology deep in the brain,” the company said.

The portable MRI system first received FDA clearance in 2020 and has received two additional FDA clearances for hardware improvements and seven clearances for upgraded software.