Hyperfine's artificial intelligence (AI) image analysis software for the company's Swoop portable MRI system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Hyperfine's Advanced AI Applications will be incorporated into the standard software package for Swoop. The software provides rapid analysis of brain images, with annotations that may be used for support in physician decision-making, the firm said.
First cleared in February 2020, the point-of-care MRI scanner is designed as a complementary tool to traditional MRI, according to the company.
