ST. PAUL, Minn., Jan. 14, 2026 /PRNewswire/ -- iotaMotion, Inc., creator of iotaSOFT®, the first and only FDA cleared robotic-assisted cochlear implant insertion system, today announced U.S. Food and Drug Administration (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.
"Receiving FDA clearance for expanded pediatric use marks a significant milestone for iotaMotion and for families navigating cochlear implant decisions," said Mike Lobinsky, CEO of iotaMotion. "By standardizing one of the most delicate steps in cochlear implant surgery, iotaSOFT helps reduce variability which could provide parents greater confidence as they consider cochlear implantation for their children."
The iotaSOFT Insertion System enables precise and controlled electrode array insertion during one of the most delicate steps of cochlear implant surgery. By standardizing this critical step, iotaSOFT is designed to help preserve delicate cochlear structures, a consideration that is often central to decision-making.
As part of this milestone, Cincinnati Children's Hospital, a nationally ranked pediatric medical center, and U.S. News & World Report Honor Roll member for 2025–2026, 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."
Globally, fewer than 5% of eligible cochlear implant candidates receive an implant, despite more than 430 million people worldwide experiencing disabling hearing loss, according to the World Health Organization. In pediatric patients, early access to sound is critical for speech, language and educational development, yet concerns around hearing preservation and surgical variability can delay intervention.
A 2025 clinical cohort study published in The Laryngoscope (Khan et al.) found that 85% of patients in the robotic-assisted insertion group maintained hearing preservation at one year, compared with 71% in the manual insertion group, according to its authors.
"Robotic assistance in cochlear implantation is about precision and consistency," said Marlan Hansen, MD, co-founder and chief medical officer of iotaMotion. "With the expanded pediatric indication for iotaSOFT, supported by growing clinical evidence, families can have greater confidence that controlled, standardized insertion is designed to protect the cochlea and preserve its structure and function. This is especially important for children who may benefit from emerging therapeutic advances, including gene-based and regenerative hearing technologies, which will likely depend on atraumatic, cochlear implant array placement early in life."
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.
Sources:
Claussen AD, et al. Comparative Analysis of Robotics-Assisted and Manual Insertions of Cochlear Implant Electrode Arrays. Otol Neurotol, 2022.
Khan AM, et al. Robotic-Assisted Electrode Array Insertion Improves Rates of Hearing Preservation. The Laryngoscope, 2025.
Data on file
Media Contact:
Sara Ashburn-Reed
Sashburn-reed@iotamotion.com
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iotaMotion Receives FDA Clearance for Expanded Pediatric Use of iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System
iotaMotion Receives FDA Clearance for Expanded Pediatric Use of iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System
iotaMotion Receives FDA Clearance for Expanded Pediatric Use of iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System
As the generative AI industry matures, Higgsfield is taking an important step towards equipping creators and studios with a new tool designed to help assess potential similarity with characters, celebrity likeness, and brands.
SAN FRANCISCO, March 14, 2026 /PRNewswire/ -- Higgsfield, the AI-native video and image platform for professional creators, announced the launch of a similarity-scoring feature for Team Plan customers. The tool evaluates AI-generated content and flags potential visual similarities to celebrity likenesses, characters, brand logos, and other potential intellectual property.
The feature arrives as Higgsfield's platform scales rapidly into commercial production. The company has doubled its user base in under two months, surpassing 20 million users, with a growing share of usage now coming from production teams running commercial campaigns. As AI-generated content moves deeper into professional workflows and elite festivals, creators and teams are increasingly expected to consider similarity, likeness, and whether a generated asset may resemble something protected.
Despite this rapid mainstream adoption, the lack of standardized safeguards remains a bottleneck for wider commercial use. Recognizing this industry-wide challenge, Higgsfield is introducing new features that empower users to make safer choices when using AI generated assets.
The new tool evaluates generated content and assigns it a similarity score to help users identify potential conflicts. Going beyond basic detection, Higgsfield's system is designed to be more nuanced than existing market solutions. The feature evaluates content to known properties, including:
- Characters from popular movies, TV, and video games (e.g., Harry Potter, Spider-Man).
- Likeness of public figures, including stylistic alterations (e.g., a celebrity rendered in unusual forms or wearing obscuring props).
- Brand logos and text assets, such as trademarked taglines.
- Famous artworks and distinct visual concepts.
- Cinematic signatures, such as distinct visual styles associated with specific directors or films (e.g., Wes Anderson, Denis Villeneuve, Alfred Hitchcock).
- Audio content, such as music and other audio content incorporated into video output.
To validate the system's efficacy, the Higgsfield Research Team conducted internal benchmark studies across diverse datasets of AI-generated and reference media. In video detection, Higgsfield's model achieved an 86.6% overall accuracy rate. Higgsfield also significantly reduced false positive rates, flagging incorrect similarities in video only 13.4% of the time.
When a potential similarity is detected, the tool identifies the nature of the similarity, the possible rights holder, and exactly where the similarity occurs in the video. Building on this initiative, Higgsfield has also launched an image model "Soul Cast", which limits image reference uploads, reducing the risk of generating someone else's likeness.
"Generative video is still a new frontier and studios, platforms, and policy experts are all still navigating the complexities of IP and likeness," said Higgsfield CEO Alex Mashrabov. "By activating our content-scoring feature, we give creators a practical way to understand their outputs before final production. We believe that proactive similarity tools like this will soon become standard across the entire generative AI ecosystem."
Higgsfield's initiative reflects a broader company commitment to the ethical and responsible commercialization of AI. For example, the company recently launched the Higgsfield Action Contest with a $500,000 prize pool, accepting nearly 8,800 submissions from all over the world. Content safety is integral to the review process along with originality and storytelling as part of the company's broader approach to building responsibly in this emerging space.
By building tools that empower human creativity while respecting intellectual property, Higgsfield aims to encourage the responsible use of AI technologies.
For more information about Higgsfield's new content-scoring feature, visit https://higgsfield.ai/app/similarity-score.
About Higgsfield
Higgsfield is an AI-native generative video platform built for professional creators, brands, agencies, and marketing teams producing high-fidelity videos at scale. The company develops its own generative video and image models and integrates leading third-party models such as OpenAI's Sora, Google's Veo and Nano Banana, Alibaba's WAN, Kuaishou's Kling, Bytedance's Seedream and Seedance, MiniMax, and others into a single, production-ready workflow, allowing teams to select the best model for each creative task without rebuilding pipelines.
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Higgsfield Launches Similarity-Scoring Tool for Responsible AI Use in Media and Entertainment
