FDA clears deep learning application to support image interpretation with Hyperfine’s Swoop™ Portable MR Imaging System

Hyperfine received 510(k) clearance from the US FDA for its deep-learning image analysis software. These Advanced AI Applications measure brain structure and pathology in images acquired by the category-defining Swoop™ Portable MR Imaging System through tools featuring automatic measurement of ventricular volume, brain extraction, brain alignment, and midline shift -- a clinical measure of brain injury.