Guilford, Conn.-based Hyperfine Research, Inc. announces that it has received 510(k) clearance from the U.S. FDA for its deep-learning image analysis software. These Advanced AI Applications measure brain structure and pathology in images acquired by the 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.

Included as part of Swoop’s standard software package, Advanced AI Applications work with Swoop to transform the system into a true bedside clinical decision support platform for evaluating brain health and injury. In just minutes after Swoop scanning, Advanced AI Applications analyze and return annotated and segmented brain images, providing clinicians of all levels of expertise with quantitative markers for decision support and immediate feedback for diagnostic insight.

“With this powerful tool now built into the Swoop system, we are making MR imaging not only accessible at the bedside but making it easier for providers to move quickly from scan to a recommended course of treatment,” says Khan Siddiqui, MD, chief medical officer of Hyperfine. “The data provided by Hyperfine’s deep learning software will liberate users of our MR technology by providing simple, accessible information in just minutes.”