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Portable Ultrasound Diagnostic System and Disposable Intracardiac Echocardiography Catheter Approved for Marketing

CCFDIE| Updated: 2025-02-19

     

Recently, the two innovative products "Portable Ultrasound Diagnostic System" and "Disposable Intracardiac Echocardiography Catheter" of Shenzhen Sonosemi Medical Co., Ltd. are approved by China NMPA.

The Portable Ultrasound Diagnostic System consists of an ultrasound main unit, a connector and a power adapter. The Disposable Intracardiac Echocardiography Catheter consists of a catheter tip, a steerable tube, an operating handle, and a tail connector, which utilizes the inverse piezoelectric effect to convert the pulsed electrical signals output from the Portable Ultrasound Diagnostic System into ultrasound waves that are emitted into the tissues of the heart cavity, and receives the return signals for transmission to the Portable Ultrasound Diagnostic System, which are converted into digital image signals and then displayed on the monitor.

These two products are used together for ultrasound imaging of the adult heart, major cardiac vessels and intracardiac anatomical structures, with greater depth of detection than similar products, and are the first intracardiac cavity ultrasound imaging system in China.

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