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iotaMotion, Inc. announced that the U.S. Food and Drug Administration (FDA) allowed for the expansion of pediatric clearance for its iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System. The system can now be used in patients aged four years and older, letting school-aged children to benefit from robotic assistance during cochlear implant surgery.
FDA 510(k) clearance means this technology, already cleared for adults, is approved for a broader age range, helping surgeons insert the electrode array with slow, consistent control meant to protect delicate cochlear structures. iotaSOFT is the first and only FDA-cleared robotic system for this purpose. The expanded clearance potentially gives families greater confidence in the surgical process, and facilities such as pediatric hospitals are beginning to adopt the technology.
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