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Intravascular Imaging Device Approved for Marketing

CCFDIE| Updated: 2023-05-16

Recently, the innovative product Intravascular Imaging Device (Novasight Hybrid System) of Conavi Medical Inc.is approved by China NMPA.

This product is composed of a console and a patient interface module (PIM), and is used in conjunction with a single-use IVUS OCT catheter for intravascular imaging of coronary arteries during percutaneous coronary interventional operation.

The imaging catheter of this product is equipped with IVUS and OCT probes at the far end, which can automatically obtain images and feedback them to the image processing module, achieving synchronous registration of intravascular ultrasound and optical interference tomography imaging. This product is superior to similar marketed products and can achieve both types of imaging simultaneously, which meets doctors' requirements for resolution and penetration, simplifies doctors' operations, and improves accuracy and safety of imaging.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.