Hyperfine Research Gets Expanded FDA Clearance for Portable MRI System

Hyperfine Research has gained an additional 510(k) clearance from the FDA for its Swoop portable magnetic resonance imaging (MRI) device that includes enhanced imaging.

The device, which is controlled using a wireless tablet, can be wheeled up to a patient’s bedside and plugs into a standard electrical wall outlet.

The new clearance allows the use of the device in newborns and patients up to two years old.