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Coronary Artery CT Fractional Flow Reserve Calculation Software approved for marketing

CCFDIE| Updated: 2023-04-04

Recently, the innovative product Coronary Artery CT Fractional Flow Reserve Calculation Software of Shanghai Pulse Medical Technology Co., Ltd. is approved by China NMPA.

This product calculates the CT fractional flow reserve score based on coronary CT angiography images, intended to assist in evaluating the functional myocardial ischemia status of stable coronary heart disease patients. It can help clinicians determine whether coronary artery stenosis causes myocardial ischemia and whether patients need further intervention and treatment. As a supplement to conventional imaging examinations, the marketing of corresponding software will further reduce the diagnostic time and expenditure burden on patients.

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