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Two Imported Devices Gain Innovation Approval in April

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The NMPA granted innovation approvals to seven devices in April 2023, for indications ranging from cardiovascular, orthopedic, neurology and ophthalmic. Among them are two imported devices.

Complete List of Innovation Approvals April

  • Alcon: Intraocular lens
  • Ubiosis: Collagen cartilage repair scaffold
  • Beijing Huake Precision: Single-use laser fiber kit
  • Beijing Huake Precision: Magnetic resonance monitoring semiconductor laser equipment
  • Shanghai Bodong: Coronary CT flow reserve fraction calculation software
  • Suzhou Runmaide: Coronary artery function measurement system
  • Beijing Aikang Yicheng: Metal additive manufacturing of thoracolumbar fusion matching prosthetic system

There have been 199 innovation devices approved since 2014. To get an English copy of innovation devices catalog, please email info@ChinaMedDevice.com.

We have translated the Innovation Device Approval Procedure for you to download today.

What are the Devices?

Alcon: Intraocular lens

The product is a one-piece backroom intraocular lens using patented wavefront shaping technology that makes full use of the light entering the eye and is expected to improve the side effects of halos and/or other visual disturbances prevalent in diffractive IOLs.

This product is intended for adult patients with preoperative corneal astigmatism < 1.00D and no lens eyes after cataract lens removal after transcapsular cataract extraction, and intraocular lens implantation for vision correction in the first stage.

The product reduces the impact of presbyopia on patients’ near, medium and distance vision by extending the depth of focus, and expands the range of vision from long distance to functional near vision while maintaining considerable distance vision, reducing patients’ dependence on glasses.

Ubiosis: Collagen cartilage repair scaffold

The product innovatively adopts the process of collagen extraction sterilization process in the production, and removes the immunogenic terminal peptide structure, which can batch and stably produce collagen materials with a complete triple helix structure.

This product uses collagen as the main component and is used as a biological scaffold to provide space for cell adhesion, proliferation and migration of autologous bone marrow mesenchymal stem cells (BMSCs).

After the collagen cartilage repair scaffold is implanted, the chondrocytes in it are differentiated by BMSCs and migrate and proliferate in the surrounding healthy cartilage tissue. Chondrocytes continuously synthesize and secrete type II collagen to form new cartilage tissue, which in turn repairs defective cartilage.

During this process, the collagen scaffold is gradually degraded, and the degradation products can be absorbed by chondrocytes as nutrients and excreted through metabolism.

Existing cartilage injury repair techniques commonly include microfractures, cartilage transplantation, chondrocytes transplantation, and joint replacement. Collagen cartilage repair stents are used in knee microfractures surgery.

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