NMPA Approves Four Innovative Medical Devices for Market Launch

01

The National Medical Products Administration (NMPA) has approved the registration application for the innovative product "Crosslinked Polyisobutylene Aspheric Intraocular Lens" from Eyedeal Medical Technology Company Limited.

This product is a single-piece posterior chamber intraocular lens (IOL), foldable with dual C-loop haptics. The IOL body and haptics are made of hydrophobic cross-linked polyisobutylene material, with an added UV absorber. The diopter range is +0.5 D to +34.0 D. The optical design of the IOL is monofocal and aspheric. This product is intended for vision correction in aphakic adult eyes after cataract removal surgery.

02

NMPA Approves Two Innovative Product Registration Applications: Shenyang Pengyue Technology Co., Ltd.'s Cardiac Cryoablation Device and Single-Use Sterile Cryoablation Probe.

The cardiac cryoablation system consists of a main unit, an argon gas delivery line, a helium gas delivery line, and an optional disposable sterile thermometer. The disposable sterile cryoablation probe is composed of a probe, a handle, connecting tubes, and thermocouple temperature sensors. These two products are used together and are mainly intended for the treatment of persistent atrial fibrillation in adult cardiac patients.

This product utilizes the cooling effect after argon gas throttling to rapidly freeze ablated myocardial cells, achieving the treatment of persistent atrial fibrillation. It features rapid rewarming, vacuum insulation, backside temperature feedback, ease of operation, and high safety, benefiting more patients with persistent atrial fibrillation.

03

The National Medical Products Administration has approved the innovative product registration application for the extended depth-of-focus intraocular lens from Eyebright Medical Technology (Beijing) Co., Ltd.

This product includes non-preloaded intraocular lenses (Model: AE2UV) and preloaded intraocular lenses (Model: AE2UL22, AE2UL24, AE2UL28). The preloaded models consist of the non-preloaded AE2UV type intraocular lens and an injector. The intraocular lens is a one-piece, foldable, posterior chamber lens with modified L-shaped haptics. The main body and support parts of the lens are primarily made from ethyl acrylate (EA) and ethyl methacrylate (EMA) polymers, with the addition of the cross-linking agent ethylene glycol dimethacrylate (EGDMA), and it undergoes plasma surface treatment. Both the front and back surfaces of the intraocular lens feature a monofocal design, with the front surface using a higher-order aspheric design and the back surface using a spherical design. This product is suitable for vision correction in aphakic adult eyes after cataract removal surgery, improving intermediate vision by extending the depth of focus to reduce dependence on glasses.

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