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iotaMotion Announces FDA De Novo Request to Market its Robotic-Assisted Cochlear Implant Insertion System

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iotaMotion has announced FDA granted its De Novo classification request to market the iotaSOFT™ insertion system. iotaSOFT is the world’s first and only robotic-assisted insertion technology intended to aid surgeons in placement of cochlear implant electrode arrays by controlling the speed of implant insertion. The system is poised to become a fixture in the cochlear implant space, designed as a small, thumb-sized, open platform robotic technology that is compatible with a variety of implants and fits seamlessly into existing surgical workflows.

“We are excited to introduce the iotaSOFT insertion system, the world’s first and only commercially authorized by the FDA robotic assisted insertion system for cochlear implantation, which objectively offers precision and control beyond human capability,” said Christopher Kaufmann, MD, President and CEO of iotaMotion. “We are thankful for the continued support of our world-renowned clinical advisors and scientific advisory board and are excited to begin commercialization of this first-of-its kind technology. The iotaSOFT system advances our vision of creating a suite of integrated capabilities to provide robotic precision, operative data analytics, and real-time guidance to all surgeons as we work together to improve outcomes for our patients.”

The iotaSOFT system is a thumb-sized bone-mounted robotic device that works in conjunction with the surgeon during insertion of the cochlear implant electrode array. The system is designed to reduce electrode array insertion variability and forces. It is compatible with a wide and growing variety of available cochlear implants. Notably, the surgeon controls the precise motion capabilities of the robotic-assisted insertion, while still using their technical skills, training, and experience.

“Historically, cochlear implant electrode arrays have been placed solely by hand with forceps and other manual instrumentation.  With the advent of robotic-assisted systems like the iotaSOFT, we will now have the ability to place the electrode into the delicate, tiny structures of the cochlea with the added precision and stability that robotic assistance provides.” said Marlan Hansen, MD, iotaMotion Medical Director and Department of Otolaryngology Chair at the University of Iowa.  “There are clear opportunities to improve outcomes, optimize preservation of existing function, and support consistent results for surgeons and patients in the US and around the world.”

“We look forward to working closely with surgeons, hospitals, and implant partners alike, in building out broad iotaSOFT system adoption with the goal of creating a new standard of care for cochlear implantation.” said Eric B. Timko, Executive Chairman of the Board. “This is the first of several applications where a minimal footprint, surgeon-friendly robotic-assisted solution will improve standardization and efficiency.”

iotaSOFT will be available to healthcare professionals and patients in the coming months through a controlled commercialization schedule. To learn more about iotaSOFT system visit https://www.iotamotion.com/iotasoft. Please refer to the labeling for a complete list of warnings, precautions and contraindications.

Source: iotaMotion Inc.

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