OrthoPediatrics Corp. (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 CEO David Bailey.
“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.”
KIDS shares collected 28 cents, or 1.6%, to $17.57.
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