OrthoPediatrics partner iotaMotion receives FDA clearance for use of its iotaSOFT® cochlear implant insertion system in patients four years and older
WARSAW, Ind., Feb. 03, 2026 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced its partner, iotaMotion, has received FDA 510(k) clearance for expanded pediatric use of its iotaSOFT® Insertion System. The system is now cleared for use in patients four years of age and older, extending access to robotic-assisted cochlear implantation for school-aged children.
OrthoPediatrics has an existing partnership with iotaMotion to bring its robotic-assisted insertion system, designed to enhance the cochlear implant surgery, to pediatric providers, caregivers, and patients. The iotaSOFT system is the first and only FDA authorized open platform robotic-assisted technology that aims to decrease surgical variability by controlling the speed and consistency of a cochlear implant electrode array insertion. The device is now indicated for children four years and older.
“This milestone allows us to leverage our existing capabilities and bring the same discipline, focus, and pediatric-first expertise beyond orthopedics. We are excited to extend our ability to help more children through improved clinical care and efficiency in the ENT space with an advanced technology like iotaSOFT,” commented David Bailey, President & CEO of OrthoPediatrics. “This partnership is a perfect strategic fit for our Enabling Technologies division where we are applying our core mission of addressing unmet pediatric needs with cutting edge digital health and advanced technology solutions. This approach supports our long-term vision to thoughtfully expand into adjacent areas of the pediatric care continuum, deepening our impact for patients, providers, and caregivers while maintaining a capital-light, cash-friendly business model supported by diverse revenue streams.”
As part of this milestone, Cincinnati Children’s Hospital, a nationally ranked pediatric medical center, has become the first dedicated pediatric center to adopt the iotaSOFT Insertion System. Cincinnati Children’s joins over 35 leading cochlear implant centers across the United States, including nearly half of U.S. neurotology fellowship training programs, that have adopted this innovative technology.
“At Cincinnati Children’s, our focus is delivering the highest standard of care while thoughtfully integrating innovations that benefit our patients,” said Dr. Daniel Choo, chief clinical growth officer and professor of otolaryngology–head and neck surgery. “Robotic-assisted cochlear implantation represents a meaningful advancement in our cochlear implant program.”
About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such, it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets over 85 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 75 countries outside the United States. For more information, please visit www.orthopediatrics.com. For more information about the OrthoPediatrics Specialty Bracing portfolio, please visit www.opsb.com.
About iotaMotion
iotaMotion, Inc. is a medical technology company based in St. Paul, Minnesota, dedicated to advancing cochlear implant surgery beyond human capability through robotic-assisted solutions. Its flagship technology, the iotaSOFT® Insertion System, is designed to preserve delicate intracochlear structures through slow and consistent electrode array insertion. The system is commercially available in the United States and under clinical investigation in other global markets.
For more information, visit http://www.iotamotion.com/ and follow us on LinkedIn, X, Facebook, YouTube.
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