Two Innovative Medical Devices Receive NMPA Approval for Market Launch

Source: National Medical Products Administration

On September 29, the National Medical Products Administration (NMPA) released a message,Two More Innovative Medical Devices Approved for Marketing in China.

Recently, the National Medical Products Administration approvedShenyang Pengyue Technology Co., Ltd.TheCardiac Cryoablation Device and Single-Use Sterile Cryoablation ProbeRegistration applications for 2 innovative products.

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.

Recently, the National Medical Products Administration approvedEyedeal Medical Technology Company LimitedCross-linked Polyisobutylene Aspheric Intraocular LensInnovative Product Registration Application.

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 suitable for vision correction in aphakic eyes following cataract extraction surgery in adults.