iotaSOFT Insertion System
Open-platform robotic-assisted system that controls electrode array insertion speed during cochlear implant surgery. FDA 510(k) cleared for patients four years of age and older (Jan 2026).
hardwaremanufacturer
Pricing envelope
—Not statedCertifications
fda_510kFDA 510(k)
src
“iotaMotion Receives FDA Clearance for Expanded Pediatric Use of iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System”https://iotamotion.com/press/iotasoft-fda-clearance-pediatrics/retrieved 2026-08-21 · extracted