iotaMotion's iotaSOFT system receives FDA clearance for pediatric cochlear implantation, partnering with OrthoPediatrics and Cincinnati Children’s Hospital.
Quiver AI Summary
OrthoPediatrics Corp. announced that its partner, iotaMotion, has received FDA 510(k) clearance for the iotaSOFT® Insertion System, now indicated for use in pediatric patients aged four and older, facilitating robotic-assisted cochlear implantation for school-aged children. This system is notable for being the first FDA-authorized open-platform robotic technology aimed at improving the consistency and speed of cochlear implant electrode array insertion. The collaboration between OrthoPediatrics and iotaMotion represents a strategic expansion into new areas of pediatric care, enhancing clinical outcomes in ENT procedures. Cincinnati Children's Hospital has become the first dedicated pediatric center to adopt this technology, joining over 35 leading cochlear implant centers across the U.S. OrthoPediatrics continues to focus on pediatric orthopedic innovation, leveraging its expertise to address unmet needs in various pediatric health sectors.
Potential Positives
- iotaMotion received FDA 510(k) clearance for expanded pediatric use of the iotaSOFT® Insertion System, enhancing OrthoPediatrics' portfolio in pediatric cochlear implantation.
- The partnership with iotaMotion validates OrthoPediatrics' strategic direction to expand into adjacent areas of pediatric care, enhancing their business model and revenue streams.
- Cincinnati Children’s Hospital adopting the iotaSOFT system signifies a major endorsement, potentially attracting other leading pediatric centers to follow suit.
Potential Negatives
- OrthoPediatrics is expanding its focus beyond pediatric orthopedics by venturing into cochlear implantation, which could dilute its brand identity and core mission of specializing solely in pediatric orthopedic care.
- While the press release states a long-term vision to thoughtfully expand services, it raises concerns about whether the company may face challenges or risks in maintaining quality and focus in its core competencies while branching out.
- Dependence on partnerships, such as with iotaMotion, may pose a risk to OrthoPediatrics’ operational stability and long-term viability if these collaborations do not yield anticipated outcomes.
FAQ
What is the FDA 510(k) clearance for iotaSOFT® Insertion System?
The FDA 510(k) clearance allows iotaSOFT to be used for pediatric patients aged four years and older in cochlear implantation.
How does the iotaSOFT® system improve cochlear implantation?
The iotaSOFT system enhances cochlear implant surgery by controlling the speed and consistency of electrode array insertion, reducing surgical variability.
What is OrthoPediatrics' role in pediatric healthcare?
OrthoPediatrics focuses on advancing pediatric orthopedics and now aims to improve clinical care in the ENT space with innovative technologies.
Which hospital first adopted the iotaSOFT® Insertion System?
Cincinnati Children’s Hospital has become the first dedicated pediatric center to adopt the iotaSOFT Insertion System.
What is the vision of OrthoPediatrics for the future?
OrthoPediatrics aims to expand into adjacent areas of pediatric care while maintaining a capital-light, cash-friendly business model with diverse revenue streams.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$KIDS Insider Trading Activity
$KIDS insiders have traded $KIDS stock on the open market 1 times in the past 6 months. Of those trades, 1 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $KIDS stock by insiders over the last 6 months:
- FRED HITE (COO and CFO) purchased 5,076 shares for an estimated $98,525
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$KIDS Revenue
$KIDS had revenues of $61.2M in Q3 2025. This is an increase of 12.23% from the same period in the prior year.
You can track KIDS financials on Quiver Quantitative's KIDS stock page.
$KIDS Hedge Fund Activity
We have seen 50 institutional investors add shares of $KIDS stock to their portfolio, and 58 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- BROWN CAPITAL MANAGEMENT LLC removed 475,484 shares (-30.5%) from their portfolio in Q3 2025, for an estimated $8,810,718
- BROWN ADVISORY INC added 270,004 shares (+16.6%) to their portfolio in Q3 2025, for an estimated $5,003,174
- NEW YORK STATE COMMON RETIREMENT FUND removed 254,500 shares (-57.1%) from their portfolio in Q3 2025, for an estimated $4,715,885
- PROSIGHT MANAGEMENT, LP added 235,060 shares (+319.2%) to their portfolio in Q3 2025, for an estimated $4,355,661
- GRANAHAN INVESTMENT MANAGEMENT, LLC removed 206,877 shares (-21.4%) from their portfolio in Q3 2025, for an estimated $3,833,430
- DEERFIELD MANAGEMENT COMPANY, L.P. added 178,623 shares (+1153.4%) to their portfolio in Q3 2025, for an estimated $3,309,884
- MILLENNIUM MANAGEMENT LLC added 162,628 shares (+20.8%) to their portfolio in Q3 2025, for an estimated $3,013,496
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$KIDS Analyst Ratings
Wall Street analysts have issued reports on $KIDS in the last several months. We have seen 6 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- BTIG issued a "Buy" rating on 10/29/2025
- Needham issued a "Buy" rating on 10/29/2025
- Lake Street issued a "Buy" rating on 10/10/2025
- Stifel issued a "Buy" rating on 10/10/2025
- JMP Securities issued a "Market Outperform" rating on 10/10/2025
- Piper Sandler issued a "Overweight" rating on 10/10/2025
To track analyst ratings and price targets for $KIDS, check out Quiver Quantitative's $KIDS forecast page.
$KIDS Price Targets
Multiple analysts have issued price targets for $KIDS recently. We have seen 8 analysts offer price targets for $KIDS in the last 6 months, with a median target of $23.5.
Here are some recent targets:
- Mathew Blackman from TD Cowen set a target price of $23.0 on 01/27/2026
- Caitlin Roberts from Canaccord Genuity set a target price of $24.0 on 12/10/2025
- Ryan Zimmerman from BTIG set a target price of $23.0 on 10/29/2025
- Mike Matson from Needham set a target price of $26.0 on 10/29/2025
- Rick Wise from Stifel set a target price of $20.0 on 10/10/2025
- David Turkaly from JMP Securities set a target price of $25.0 on 10/10/2025
- Matt O'Brien from Piper Sandler set a target price of $22.0 on 10/10/2025
Full Release
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 Hospita l , 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 .
Investor Contact
Philip Trip Taylor
Gilmartin Group
[email protected]
415-937-5406
