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Coronary Function Measurement System Approved for Marketing

CCFDIE|Updated: 2023-04-20

     

Recently, the innovative product Coronary Function Measurement System of Suzhou RainMed Medical Technology Co., Ltd. is approved by China NMPA.

The product is composed of work station, transducer rack, IBP lead wire and IBP signal input cable(optional), and only applied with the disposable invasive pressure transducer of Suzhou RainMed Medical Technology Co., Ltd. It is intended to assess Coronary Angiography Index of Microcirculatory Resistance (caIMR) by conducting vascular segmentation and three-dimensional reconstruction on coronary angiography images, and making hemodynamic analysis combing with the aortic pressure measured by disposable invasive pressure transducer, which assists clinicians to assess the function of coronary microcirculation for patients.

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