FDA Approves iotaMotion’s Cochlear Implant Insertion System

IotaMotion has received the FDA’s De Novo approval for its iotaSOFT cochlear implant insertion system.

The robotic-assisted insertion system is designed to aid surgeons in placement of cochlear implant electrode arrays by controlling the speed of implant insertion, according to Iowa City, Iowa-based iotaMotion.

The thumb-sized, open platform device is compatible with a variety of implants and is intended to reduce electrode array insertion variability, the company said.