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Two Cardio Imaging Devices Gain Innovation Approval


nmpa guidelines for nanomaterials

The NMPA granted innovation approvals to two radiology devices, used in combination for ultrasound imaging of intravascular lesions in coronary arteries.

  • Intravascular ultrasound diagnostic equipment
  • Single-use intravascular ultrasound diagnosis catheter

There have been 185 innovation devices approved since 2014. To get an English copy of innovation devices catalog, please email

We have translated the “Innovation Device Approval Procedure” for you.

What are the Devices

The two devices are made by two manufacturers. In the approval notice, NMPA says that: “These two products use the principle of pulse echo to image blood vessels with ultrasound scans.

The main machine of the equipment and the catheter controller send an excitation pulse to the ultrasonic transducer located at the far end of the catheter, and at the same time drive the transducer to rotate at high speed through the drive shaft inside the catheter sheath, and the transducer sends ultrasonic pulses and accepts the ultrasonic echo signal reflected by the vascular tissue, which is amplified, collected, and preprocessed by the catheter controller and transmitted to the host to realize the display and processing of vascular images.

The intravascular ultrasound diagnostic equipment adopts full digital signal transmission and single-array mechanical rotation design, and the digital transmission between the catheter controller and the imaging host is realized, which improves the integration and stability of the system while reducing the cost and making the image noise smaller. “

The process design and method of preparing a glue layer without glue layer and a thickness ≤of 15μm on the PMN-PT high-frequency single-crystal composite transducer using single-vessel ultrasound catheter, which realizes the localization of high-performance high-frequency transducer production, improves image resolution, and optimizes image quality.

This supporting product uses high-frequency, wide-bandwidth, high-sensitivity ultrasound imaging, which can realize coronary blood vessel scanning imaging and blood vessel diameter measurement, help doctors judge the severity and nature of lesions, help improve the understanding of coronary artery lesions and guide interventional treatment.”

About China Med Device

China Med Device provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.

Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, IVDs draft guidelines, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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