Innovative Implantable Ocular Muscle Nerve Stimulator i-NYS Gains Market Approval in China

(Source: China Food and Drug Administration Network)

On March 17, the website of the National Medical Products Administration released "Implantable Ocular Muscle Neurostimulator Approved for Marketing," the full text is as follows.

Implantable Ocular Muscle Neurostimulator Approved for Marketing

Recently, the National Medical Products Administration approved the registration application for the implantable ocular muscle neurostimulator from Super Vision Technology, Inc.

The product, composed of a stimulator, receiving coil, electrode array, annular electrode, and internal magnet, is used in conjunction with specific external power supply equipment to improve congenital horizontal nystagmus symptoms in patients aged 8 years and above.

This product adopts implantable extraocular muscle neuromuscular stimulation technology, which improves horizontal nystagmus symptoms through electrical stimulation of the extraocular rectus muscles by electrodes. Compared with existing clinical treatment options, it features minimal local trauma, strong controllability, and stable therapeutic effects, making it a globally pioneering product. The market launch of this product provides a new treatment approach for improving congenital horizontal nystagmus symptoms.

The drug regulatory department will strengthen the post-market supervision of the aforementioned products to ensure patient safety in medical device usage.