Five Innovative Medical Devices Approved in October, Bringing China's Total to 378

　　【Pharmaceutical Network Industry DynamicsOn October 31, 2025,重磅消息 came from the website of the National Medical Products Administration. The innovative product registration application for the cardiac electrophysiology interventional surgery control system of Shaoxing Mayo Heart Magnetic Medical Technology Co., Ltd. was officially approved. This news not only adds another strong contender to China's medical device innovation field but also marks that up to now, a total of 378 innovative medical device products in China have been successfully approved for marketing. Notably, in October alone, five innovative medical device products passed the review smoothly, showcasing the robust momentum of development in China’s medical device innovation sector.
 

Data shows that the cardiac electrophysiology interventional surgery control system approved this time 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. The product is used in conjunction with disposable electrophysiology interventional device control system transmission components to assist clinicians in manipulating compatible force-sensing radiofrequency ablation catheters and sheaths during atrial fibrillation catheter radiofrequency ablation procedures. This product employs a teleoperation system to perform electrophysiology catheter ablation surgeries, replacing the traditional method where the surgeon manually operates the catheter and sheath at the bedside. During surgery, the product can provide real-time graphical representation of the catheter-sheath relationship, addressing the issue of fixed-curve sheaths being invisible in 3D mapping systems in traditional surgeries, thus enhancing surgical safety.
 

In addition to the aforementioned products, other innovations approved in October include: GenLight's magnetic resonance-guided semiconductor laser treatment device, single-use laser fiber kit, and stereotactic surgical planning software; Tianjin Century Kangtai Biomedical Engineering Co., Ltd.'s innovative product, the extended depth-of-focus intraocular lens.
 

Among them, GenLight's magnetic resonance-guided laser ablation system, used in conjunction with a disposable laser fiber kit, is applied for the laser treatment of local lesions in patients with drug-resistant epilepsy (focal seizures, with a clearly identified epileptogenic zone or a defined epileptic pathway). The stereotactic surgical planning software, used together with the magnetic resonance-guided laser ablation system, is utilized for formulating head stereotactic surgical plans. The product can significantly reduce damage to normal brain tissue caused by the surgical pathway and better preserve cognitive function.
 

Century Kaitai Biotech's "Extended Depth-of-Focus Intraocular Lens" is a single-piece posterior chamber intraocular lens, with both the main body and haptics made of hydrophobic acrylic material. The anterior optical zone features an aspheric surface combined with diffractive rings, while the posterior surface is spherical, utilizing multiple diffraction orders to achieve extended depth-of-focus. It is suitable for vision correction in aphakic adult eyes after cataract removal surgery, reducing dependence on glasses by improving intermediate vision through extended depth-of-focus.
 

The centralized approval of these 5 innovative medical device products in October has not only enriched the types of medical devices in China but also achieved technological breakthroughs and innovations in multiple disease treatment fields. From cardiac disease treatment to epilepsy treatment, and post-cataract surgery vision correction, these innovative products accurately meet clinical needs, providing patients with safer and more effective treatment options, and injecting strong momentum into the high-quality development of China's healthcare industry. It is believed that as China’s medical device innovation capabilities continue to improve, more outstanding innovative products will emerge in the future, contributing greater strength to safeguarding the life and health of the people.
 

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