Shenzhen Institute of Advanced Technology Receives NMPA Approval for Ultra-High Definition Dual-Frequency IVUS
The ultra-high definition dual-frequency intravascular ultrasound (IVUS) imaging diagnostic device and its accompanying catheter, developed by Professor Ma Teng’s research team at the Shenzhen Institute of Advanced Technology (SIAT), Chinese Academy of Sciences, has received approval through the Innovation Medical Device Special Review Procedure of China Medical Products Administration (NMPA). The product represents the institute’s practice of building a complete chain from original innovation to clinical implementation.
Unlike traditional coronary angiography, which primarily observes whether the vessel lumen is narrowed, intravascular ultrasound delivers a miniature ultrasound probe inside the blood vessel. This allows visualization of fine structures, including the lumen, vessel wall, plaque, calcium deposits, and stent apposition. This helps physicians assess lesion characteristics and evaluate post-procedure outcomes. The team successfully developed 90 MHz ultra-high-frequency transducer technology, achieving the world’s highest operating frequency for intravascular ultrasound in human patients. This technology has an axial resolution of 15 micrometers, which is comparable to optical coherence tomography. This is the world’s first clinical application of a 90 MHz ultrasound transducer in humans.
The team further innovated a dual-frequency fusion architecture, integrating both 60MHz and 90MHz transducers within a single catheter. The 60MHz transducer provides a wide view of the overall vessel architecture, while the 90MHz transducer captures fine structural details. Through back-to-back precision packaging and automatic image registration algorithms, a single pullback produces two complementary views on the same screen. This represents the world’s first dual-frequency intravascular ultrasound imaging within a single interventional catheter, addressing both resolution and penetration depth challenges.
With support from SIAT, the team formed an innovation consortium including the National Innovation Center for Advanced Medical Devices and Haoying Medical, responsible for original research, platform coordination, and industrial translation, respectively. Through regular technical exchanges integrating clinical feedback directly into transducer design, the team completed the journey from concept to Class III medical device registration within five years. Professor Ma Teng stated that receiving regulatory approval is not the finish line but the starting point for serving patients. The product aims to achieve technological self-sufficiency in high-end domestic medical devices and bring scientific innovation from the laboratory to the patient’s bedside.
