Tag: FDA

AI-based brain-mapping software receives FDA market authorization

Technology developed at WashU Medicine locates sensitive areas to enhance precision neurosurgery By: Mark Reynolds A new AI-based technology that rapidly maps the brain to locate sensitive areas that control speech, vision, movement and other critical functions has received authorization from the Food and Drug Administration (FDA), enabling it to be marketed to hospitals with […]

Device for noninvasive brain biopsies via blood draw moves closer to market approval

FDA grants WashU-based technology ‘Breakthrough Device’ designation A device aimed at enabling neurosurgeons and other physicians to perform noninvasive blood-based biopsies in adults with brain tumors has received Food and Drug Administration (FDA) “Breakthrough Device” designation. The device includes technology from Washington University in St. Louis and developed by Cordance Medical Inc., a medical device […]