Dec 2019 PRNewswire
iotaMotion, Inc., an early-stage medical technology startup spun out of the University of Iowa's Otolaryngology Department, announced today that the company has filed a De Novo application seeking FDA authorisation to market in the US its cochlear implant insertion system. The Company is utilising the FDA's De Novo pathway as there is no predicate device with a comparable indication in the US market.
The iotaSOFT™ system is intended to aid surgeons in the placement of cochlear implant electrode arrays. Currently, a significant percentage of hearing preservation cochlear implant patients still suffer from hearing loss over time. A key driver in these outcomes is damage to the delicate cochlea tissue which can occur by manually inserting the cochlear implant electrode arrays.
"This is a meaningful milestone for iotaMotion, signaling the unique positioning that our iotaSOFT insertion technology will have in the marketplace," said Eric B. Timko, Executive Chairman of iotaMotion. "Alongside our De Novo application, we are planning initial commercial activities for an impactful launch led by some of the world's leading experts in cochlear implant surgery, once the FDA has authorised."
The Company's technology will enable surgeons to achieve more precise, effective solutions for patients experiencing various types of hearing loss. The iotaSOFT system will allow surgeons to advance cochlear implant electrodes with the control and precision of computers. iotaMotion anticipates that controlled insertion will allow for less surgical variability in outcomes and results.
"Our technology will allow cochlear implant surgery to take a much needed step forward," said Christopher R. Kaufmann, MD, President and co-founder of iotaMotion. "We're seeing implant technology continue to advance, opening up the addressable market and bringing more capabilities into surgeons' hands; our company's opportunity lies in delivering unprecedented control, precision and reproducibility alongside those implant advancements.”