Hangzhou Jialiang Medical Technology Receives NMPA Approval for Innovative MR-Guided Laser Ablation System, Disposable Laser Fiber Kit, and Stereotactic Surgical Planning Software

Source: Website of the National Medical Products Administration

Recently, the National Medical Products Administration approved the registration applications of three innovative products from Hangzhou Genlight Neurotech Co., Ltd.: an MRI-guided semiconductor laser treatment device, a single-use laser fiber kit, and stereotactic surgical planning software.

The magnetic resonance (MR)-guided semiconductor laser therapy system consists of a main unit and accessories. The single-use laser fiber kit is composed of a medical fiber optic catheter assembly and cooling water tubing. The stereotactic surgical planning software includes an installation USB drive and security key. The MR-guided semiconductor laser therapy system, when used with the single-use laser fiber kit, is intended for laser treatment of localized lesions in patients with drug-resistant epilepsy (focal seizures with a well-defined epileptogenic zone or clear seizure propagation pathway). The stereotactic surgical planning software, when paired with the MR-guided semiconductor laser therapy system, is used to develop head stereotactic surgical plans.

This product can minimize the damage of surgical access to normal brain tissue and better preserve cognitive function.

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