Four Innovative Medical Devices Approved for Market Launch: Jialiang Medical and MeoHeart Magnetics Advance Neurological and Cardiac Interventions

Recently, the National Medical Products Administration approved the registration applications for four innovative products, respectively:

Three innovative medical devices from Hangzhou Genlight Medical Technology Co., Ltd. (hereinafter referred to as "Genlight Medical"): MRI-monitored semiconductor laser treatment equipment, disposable laser fiber optic kits, and stereotactic surgical planning software;

The cardiac electrophysiology interventional surgery control system of Shaoxing Mayo Heart Magnetic Medical Technology Co., Ltd. (hereinafter referred to as "Mayo Heart Magnetic").

Source of the image: NMPA official website

GenLight Medical
The Advent of Three Major Innovative Devices

According to the information disclosed on the NMPA official website, the magnetic resonance-guided semiconductor laser treatment device 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 consists of an installation USB drive and a security key.

Among them, the magnetic resonance-guided semiconductor laser ablation system, used in conjunction with a single-use laser fiber kit, is applied for laser treatment of local lesions in patients with drug-resistant epilepsy (focal seizures, with a defined epileptogenic zone or a clear epileptic pathway). The stereotactic surgical planning software, used together with the magnetic resonance-guided semiconductor laser ablation system, is utilized for creating head stereotactic surgical plans.

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

It is reported that Genlight Neurotech, established in 2020, is committed to becoming an innovative leader in neuro-medical solutions. Since its founding, the company has developed three advanced technology platforms: brain-computer modulation, medical lasers, and brain-computer chips, providing innovative device solutions for various neurological disorders.

In addition to the three innovative medical devices launched this time, Genlight Neurotech also launched a Class III device in September this year — intracranial deep electrodes. Moreover, it has another product in the innovation pipeline, a laser ablation fiber kit. The product pipeline is rich and quite powerful.

Image Source: PharmCube Medical Device Data

Mayo Heart Magnet
Cardiac Electrophysiology Interventional Surgery Control System

According to the information on the NMPA official website, the cardiac electrophysiology interventional surgery control system developed by Mayo Heart Magnetic consists of an actuator (including a front-end robotic arm and front-end drive platform, rear-end robotic arm and rear-end drive platform), an operator, and a workstation. This product is used in conjunction with disposable electrophysiology interventional device control system transmission components to assist clinicians in manipulating compatible pressure-sensing radiofrequency ablation catheters and sheaths during atrial fibrillation catheter radiofrequency ablation procedures.

Moreover, the product employs a teleoperation system to perform electrophysiological catheter ablation surgery, replacing the traditional method of manual operation of catheters and sheaths by the surgeon at the bedside. The product can provide real-time graphical representation of the catheter-sheath relationship during surgery, addressing the issue of non-visibility of fixed-curve sheaths within the 3D mapping system in traditional surgeries, thus enhancing surgical safety.

Notably, this product is the first cardiac interventional surgery robot in China to have completed multi-center clinical trials and gained approval for market release.

It is reported that Mayo Heart Magnetic, founded in June 2018, is a high-tech enterprise specializing in the development of cardiac interventional surgery navigation technology and medical robots. According to Pharmcube data, Mayo Heart Magnetic has completed multiple rounds of financing, with most investment funds being used for product pipelines and ongoing research and development.

Image Source: Pharma Data

In addition to the innovative product launched this time, Mayo Heart Magnet has already introduced two other products, showcasing its strong R&D capabilities.

Image Source: PharmCube Medical Device Data

Conclusion

With the support of policies and the promotion of continuous technological development, the "gold content" of domestically produced medical devices in China is increasing, and local medical devices are continuously shining with new brilliance.

Editor: Mu Mian

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