From Scientific Instrument to Medical Device: SIAT's Dual-Frequency IVUS System Gains Market Approval

The National Medical Products Administration (NMPA) has granted Class III medical device registration to an ultra-high-definition dual-frequency intravascular ultrasound (IVUS) imaging system and catheter developed by the Shenzhen Institute of Advanced Technology (SIAT) and its partners. This innovative system addresses the limitations of conventional single-frequency IVUS by integrating 60 MHz and 90 MHz transducers into a single catheter to balance penetration depth with high resolution. The approval marks a significant milestone in the translation of advanced scientific instrumentation into clinical diagnostic tools for the coronary intervention market.

Developed by Professor MA Teng's team at SIAT in collaboration with the National Innovation Center for Advanced Medical Devices and Shenzhen Vista Vision Medical Technology Co., Ltd., the system received approval through the NMPA’s Special Review Procedure for Innovative Medical Devices. The technology integrates dual transducers—60 MHz for broad visualization of vessel morphology and 90 MHz for capturing fine structural details—into a single intravascular catheter. This dual-frequency design allows for an axial resolution of approximately 15 μm on the 90 MHz channel, which is critical for identifying thin fibrous caps, microcalcifications, and ensuring precise stent apposition.

The system leverages advanced materials and engineering, including single-crystal composite materials, precise poling, and meticulous packaging to ensure high-quality imaging. A single pullback generates complementary views on the same screen through automatic image registration, significantly enhancing the "third eye" capabilities of coronary intervention. Furthermore, the platform incorporates SIAT’s expertise in precision electromechanical control and AI algorithms to support high-speed pullback imaging, computer-aided lesion assessment, and three-dimensional stent reconstruction, which are designed to improve workflow efficiency within catheterization laboratories.

The path to commercialization was facilitated by an innovation consortium that managed the transition from laboratory prototype to stable production and regulatory approval within five years. SIAT led the foundational research, while the National Innovation Center coordinated clinical-trial design and Vista Vision Medical Technology handled engineering development, GMP pilot production, and the regulatory submission process. This collaborative model demonstrates a successful framework for domestic innovation in China's high-end medical device sector, moving from scientific-instrument concepts to clinically validated Class III medical devices.