An AI application that interprets MRI scans of the brain for signs or confirmation of injury has received 510(k) clearance from the FDA.
Hyperfine Research of Guilford, Connecticut, announced the development this week, saying the algorithms work with the company’s portable MRI machine called Swoop and are included in the system’s standard software setup.
The Swoop system is portable, and Hyperfine is positioning the newly approved AI capability as a way to equip clinicians at all levels of expertise with images, interpretative aids and annotations right at the bedside.
The company says the AI helps quickly deliver segmented images along with such measurements as ventricular volume, brain alignment and midline shift (a clinical measure of brain injury).
Announcement here.