Hyperfine Gets FDA’s 510(k) Clearance for ‘Deep Learning’ Portable MRI

Hyperfine has received the FDA’s 510(k) marketing clearance for its magnetic resonance imaging (MRI) reconstruction software.

The machine learning-based software enables the company’s Swoop portable MRI device to deliver accurate T1, T2 and FLAIR images used in brain imaging.

The improved image quality can support more accurate and faster diagnoses, the Guilford, Conn.-based company said.