NEW YORK, March 16, 2026 (GLOBE NEWSWIRE) — A groundbreaking advancement in ophthalmology has been achieved as Super Vision Technology announced that its i-NYS (Extraocular Neuromuscular Stimulator Implant), the world’s first implantable treatment device for congenital nystagmus, has received market approval from the National Medical Products Administration (NMPA). The device has been officially authorized for commercialization in China (Registration No.: 20263120535), marking a major milestone in addressing a condition long considered one of the most difficult to treat in ophthalmology.
Congenital Nystagmus: The “Incurable” Disease in Ophthalmology
Congenital nystagmus (CN) involves involuntary, rhythmic, to-and-fro oscillations of the eyes. Patients often experience varying degrees of visual impairment, binocular visual dysfunction, and/or abnormal head position. It typically manifests between 3-6 months after birth and persists for life. With no significantly treatment available, congenital nystagmus has been regarded as an ‘incurable’ condition in ophthalmology.
Statistics indicate the prevalence of congenital nystagmus is between 1‰-3‰. The incidence among preterm infants is approximately six times higher than in full-term infants. There are about 1.3 million patients in China and roughly 7 million globally.
A New Therapeutic Breakthrough, Ushering in the i-NYS
i-NYS is an implantable extraocular neuromuscular stimulator developed by Super Vision Technology based on the R&D of Professor Wang Lejin from the Ophthalmology Department of Peking University People’s Hospital. The device fundamentally intervenes in the pathological rhythm of nystagmus by using microcurrent stimulation to regulate extraocular muscle movement, offering a novel solution for this long-standing therapeutic challenge.
Clinical trial data demonstrates the efficacy and safety of i-NYS for congenital nystagmus. i-NYS significantly increases patients’ macular foveal fixation time, reduces nystagmus amplitude and frequency, shows favorable long-term prognosis, and thereby improves patients’ visual function and quality of life.
Two Decades of Development: From Concept to Clinic
The implantable extraocular neuromuscular stimulator, i-NYS, as the world’s first and only approved Class III active implantable medical device for treating congenital nystagmus, is the result of over 20 years of innovative R&D by Professor Wang Lejin’s team.
The clinical concept was proposed in 2004; IIT clinical validation was completed in 2015; in January 2024, i-NYS entered the NMPA’s “green channel” for innovative medical device review; in October 2024, multi-center clinical trials in China and one-year follow-up were completed, involving 45 adult and 26 pediatric patients at Beijing Chaoyang Hospital, Beijing Tongren Hospital, and Beijing Children’s Hospital; in June 2025, it received HUD designation from the US FDA; and in March 13, 2026, it officially received market approval from the National Medical Products Administration (NMPA).
A Chinese Solution, Offering a New Choice for the World
i-NYS was independently developed by a Chinese research team. The approval of i-NYS in China not only brings hope to patients with congenital nystagmus, but also highlights significant progress in the development of innovative therapies within China’s ophthalmology field, injecting strong momentum and broad prospects into the advancement of ophthalmic medicine.
About Super Vision Technology
Super Vision Technology is a global high-end ophthalmic medical device and medical microchip R&D company. Focusing on multiple cutting-edge technological fields, its core research areas include implantable neuromuscular electrical modulation technology, innovative crosslinking biomechanical modulation technology, AI-based image recognition in ophthalmology, and “visual reconstruction” brain-computer interface technology. Super Vision Technology has been driven by independent innovation, actively advancing R&D and clinical translation of domestic high-end medical devices, to provide new solutions for visually impaired patients worldwide.
http://www.supervisiontech.cn/#/home
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liu ming
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