China Approves World’s First Implantable Device for Congenital Nystagmus Treatment

Key Takeaways

• China has approved the world’s first implantable device (i-NYS) for treating congenital nystagmus, a condition long considered incurable

• The device uses microcurrent stimulation to regulate eye muscle movement, significantly improving visual stability and quality of life in clinical trials

• Developed over 20+ years by a Chinese research team, the breakthrough marks a major step forward in both ophthalmology treatment and medical innovation

Super Vision Technology has announced that its i-NYS (Extraocular Neuromuscular Stimulator Implant) has received market approval from China’s National Medical Products Administration (NMPA). The company says the approval makes the device the world’s first implantable treatment for congenital nystagmus. The device, registered under No. 20263120535, is now authorized for commercialization in China. 

Congenital nystagmus (CN) is characterized by involuntary, rhythmic eye movements that impair visual stability. The condition typically emerges between 3 and 6 months after birth and persists throughout life. Patients often experience reduced vision, binocular dysfunction, and abnormal head posture.

The disorder affects an estimated 1% to 3% of the population, with a notably higher incidence among preterm infants—approximately six times that of full-term births. Globally, around 7 million people live with CN, including approximately 1.3 million patients in China.

Despite its prevalence, effective treatments have remained elusive, with most approaches offering only limited symptom management rather than addressing the underlying pathology.

The newly approved i-NYS device represents a fundamentally new approach. Developed by Super Vision Technology based on the research of Professor Wang Lejin of Peking University People’s Hospital, the implant works by delivering microcurrent stimulation to the extraocular muscles.

This stimulation helps regulate abnormal eye movement patterns by intervening directly in the pathological rhythm of nystagmus. Unlike traditional therapies, i-NYS targets the neuromuscular mechanism underlying the condition.

Clinical trial data has demonstrated both safety and efficacy. Patients treated with i-NYS showed:

• Increased macular foveal fixation time

• Reduced amplitude and frequency of eye oscillations

• Improved visual function

• Enhanced overall quality of life