iotaMotion, Inc. has received U.S. Food and Drug Administration 510(k) clearance to expand the approved use of its iotaSOFT Robotic-Assisted Cochlear Implant Insertion System for children as young as four years old. This regulatory milestone makes the iotaSOFT system the first robotic-assisted cochlear insertion platform authorized for use in school-aged pediatric patients, expanding access to […]
BrainSpace, a U.S.-based medical technology company, has received 510(k) clearance from the U.S. Food and Drug Administration for Intellidrop, a fully automated cerebrospinal fluid (CSF) drainage and intracranial pressure (ICP) monitoring system. The cleared indication covers ventricular or lumbar use in patients requiring external CSF drainage and continuous pressure monitoring—making it potentially relevant across a […]
