Two Innovative Medical Devices Approved in China: Trifocal Intraocular Lens and Adjustable Pulmonary Artery Thrombectomy Stent System

Jun 02, 2026 10:17 CST Updated 10:17

simedice

High-end Ophthalmic Medical Device R&D and Manufacturer

ShineyoMedical

Provider of Atrial Fibrillation Electrophysiology and Peripheral Vascular Intervention Solutions

Source:SiYuMedTech

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On June 1, 2026, the National Medical Products Administration (NMPA) approvedSimediceofTrifocal Intraocular Lens (National Medical Device Registration No. 20263161111)）andShineyoMedicalofAdjustable Curved Pulmonary Artery Embolectomy Stent System (NMPA Registration No. 20263031112)）Registration Application for Innovative Products.

To date, the cumulative number of innovative medical devices marketed in China has reached425 items。

I.Trifocal Intraocular Lens

This product is a one-piece posterior chamber intraocular lens, foldable, with an optimized C-shaped haptic. The main body and haptics are made of hydrophobic acrylic copolymer material, with added UV and partial blue light absorbers. Optical design: trifocal, aspheric design. Suitable forVisual Correction of Aphakia in Adult Cataract Patients, with the expectation of improvementNear, Intermediate, and Distance Vision with Reduced Dependence on GlassesThis intraocular lens is intended for implantation within the capsular bag.

# Company Profile

Henan Simedice Biotechnology Co., Ltd.Established in Zhengzhou, China, in October 2018, the company is a Sino-US joint venture invested and controlled by Shanghai Haohai Pharmaceutical Development Technology Co., Ltd. Integrating research and development, manufacturing, and sales, it specializes in the field of high-end ophthalmic medical devices. Leveraging its independently developed MOM Intelligent Manufacturing Platform, the company utilizes advanced U.S. technologies and imported equipment to research, develop, and manufacture a series of high-end intraocular lens products, includingSingle-vision, astigmatism-correcting, multifocal, and other types, the product featuresHydrophobic aspheric design, nanoscale injection molding, customized spherical aberration correction, etc.Features: Provides high-quality vision correction solutions for cataract patients. The company’s core team possesses extensive R&D and manufacturing experience with multinational pharmaceutical enterprises. Its products have obtained multiple international certifications, and its business operations span 28 countries and regions across Asia, Europe, and the Americas.

II.Adjustable Curved Pulmonary Artery Embolectomy Stent System

This product is available in steerable and coated types, and consists of a thrombectomy stent catheter, an aspiration catheter, and accessories. It is indicated for catheter-based thrombus removal treatment in patients with acute high-risk pulmonary embolism or intermediate-risk pulmonary embolism accompanied by clinical deterioration, meeting any of the following criteria: (1)Patients with thrombi in the main pulmonary artery or its major branches who have a high risk of bleeding or contraindications to thrombolysis；（2）Patients with thrombi in the main pulmonary artery or its major branches who have failed thrombolytic therapy or aggressive medical management。

# Company Profile

ShineyoMedicalEstablished in May 2020 and located in the Zhangjiang High-Tech Park in Shanghai, the company is an innovative medical device enterprise specializing in minimally invasive interventional cardiovascular therapy. Leveraging three core technology platforms—active devices, interventional catheters, and biomaterials—the company focuses on two key areas: cardiac electrophysiology and peripheral vascular intervention. Its core products includeRHYTHPULSE^®Multi-channel Pulsed Field Ablation (PFA) System(Approved for market launch in February 2025, becoming the first domestically produced PFA system to integrate multi-channel, large-lesion, and targeted ablation capabilities) andVenous Closure SystemThe company’s core team hails from leading domestic and international industry players such as Medtronic and MicroPort, boasting over a decade of experience and nearly 100 patent applications to date. It is committed to becoming a leading provider in China of electrophysiology solutions for atrial fibrillation and peripheral vascular interventional solutions.

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