NEW YORK, March 16, 2026 — A major breakthrough in the field of ophthalmology has been announced by Super Vision Technology, as its i-NYS (Extraocular Neuromuscular Stimulator Implant)—the world’s inaugural implantable device for treating congenital nystagmus—has secured market authorization from the National Medical Products Administration (NMPA). Officially cleared for commercial use in China (Registration No.: 20263120535), this approval represents a significant milestone in addressing a condition long regarded as one of the most challenging to manage in ophthalmic medicine.
Congenital Nystagmus: An “Incurable” Ophthalmic Condition
Congenital nystagmus (CN) is characterized by involuntary, rhythmic, back-and-forth eye oscillations. Those affected often suffer from varying levels of visual impairment, binocular dysfunction, and abnormal head positioning. Typically appearing between three and six months of age, the condition is lifelong. Due to a lack of effective treatment options, congenital nystagmus has historically been labeled an ‘incurable’ ophthalmic disorder.
Data suggests that the prevalence of congenital nystagmus ranges from 1‰ to 3‰, with the incidence rate in preterm infants being approximately six times higher than in those born at full term. Currently, there are roughly 1.3 million patients in China and approximately 7 million worldwide.
A Therapeutic Innovation: Introducing the i-NYS
The i-NYS is an implantable extraocular neuromuscular stimulator developed by Super Vision Technology, building upon research led by Professor Wang Lejin of the Ophthalmology Department at Peking University People’s Hospital. By utilizing microcurrent stimulation to regulate extraocular muscle activity, the device directly addresses the pathological rhythm of nystagmus, providing a novel approach to this long-standing clinical hurdle.
Clinical trial results confirm the safety and efficacy of the i-NYS for treating congenital nystagmus. The device has been shown to significantly extend macular foveal fixation time, decrease the amplitude and frequency of nystagmus, and provide positive long-term outcomes, thereby enhancing the visual function and overall quality of life for patients.
Two Decades of Progress: From Concept to Clinical Application
As the world’s first and only approved Class III active implantable medical device for congenital nystagmus, the i-NYS is the culmination of over 20 years of dedicated R&D by Professor Wang Lejin’s team.
The clinical concept was first introduced in 2004, with IIT clinical validation finalized in 2015. In January 2024, the i-NYS was granted entry into the NMPA’s “green channel” for innovative medical devices. By October 2024, multi-center clinical trials and one-year follow-ups were completed in China, involving 45 adult and 26 pediatric patients across Beijing Chaoyang Hospital, Beijing Tongren Hospital, and Beijing Children’s Hospital. The device received HUD designation from the US FDA in June 2025, followed by official market approval from the NMPA on March 13, 2026.
A Chinese Innovation for Global Patients
Independently developed by a Chinese research team, the approval of the i-NYS in China not only offers new hope to those living with congenital nystagmus but also underscores the significant strides made in innovative ophthalmic therapies within China, providing strong momentum for the future of eye care.
About Super Vision Technology
Super Vision Technology is a global enterprise specializing in the R&D of high-end ophthalmic medical devices and medical microchips. The company focuses on several advanced technological sectors, including implantable neuromuscular electrical modulation, innovative crosslinking biomechanical modulation, AI-driven ophthalmic image recognition, and “visual reconstruction” brain-computer interface technology. Committed to independent innovation, Super Vision Technology actively advances the research and clinical translation of domestic high-end medical devices to deliver new solutions for visually impaired individuals globally.
http://www.supervisiontech.cn/#/home
PR@supervisiontech.cn
liu ming
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