China's First High-End Intravascular Imaging System Receives FDA Approval: From Domestic Substitution to Global Innovation

On April 11, the multimodal coronary optical coherence tomography (OCT) system and its accompanying catheter, independently developed by a Chinese innovative enterprise, officially received clearance from the U.S. Food and Drug Administration (FDA). This marks it as the world’s first FDA-cleared multimodal coronary OCT system and China’s first FDA-approved intravascular imaging device, signifying a major breakthrough for China in the field of high-end medical equipment.

Three FDA-Approved Products

The newly approved multimodal OCT system was independently developed by Shenzhen Vivolight Medical Device & Technology Co., Ltd. (hereinafter referred to as “Vivolight”). It enables comprehensive diagnostic assessment of vascular structure, hemodynamic function, and high-risk plaque identification through a single OCT pullback using just one catheter. This technological breakthrough successfully overcomes the historical challenge of integrating multiple devices, eliminates the need for multiple catheters and consumables, significantly reduces procedural time and material costs, and substantially improves both surgical efficiency and diagnostic accuracy, thereby providing clinicians with more robust support for diagnosis and treatment.

According to reports, Vivolight was founded in 2012 and has accumulated over thirteen years of experience in laser medicine, fiber-optic catheters, and imaging algorithms. Previously, Vivolight’s OCT devices had broken the long-standing dominance of multinational corporations, with its domestic market share second only to the multinational giant Abbott. In 2023, Vivolight became the first Chinese OCT manufacturer to enter overseas markets.

Zhu Rui, Founder and CEO of Vivolight, stated, “This FDA clearance not only opens up sales channels in the United States but also grants market access in over 20 countries and regions across Southeast Asia, the Middle East, and Latin America. This will significantly accelerate the registration process for Vivolight’s OCT products in multiple countries, facilitate the company’s global expansion, and deliver Chinese solutions to the world.”

Data show that the number of patients with cardiovascular diseases in China has exceeded 330 million. The widespread adoption of intravascular imaging technologies will significantly enhance the precision of percutaneous coronary intervention (PCI) procedures and reduce the risk of postoperative complications. In 2024, the European Society of Cardiology (ESC) upgraded intravascular diagnostic techniques, such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS), to a Class Ia recommendation (the highest level) in its guidelines for the management of chronic coronary syndromes. However, traditional OCT devices are mostly designed with single-function capabilities, making it difficult to meet the precise diagnostic requirements for complex coronary lesions. Meanwhile, the high costs of equipment and consumables remain the primary bottleneck restricting their widespread adoption.

Notably, Vivolight’s self-developed catheter components have achieved full localization in China, with core modules manufactured via robotic automation. This has significantly reduced production costs and effectively mitigated export tariff barriers amid the current volatile foreign trade environment.

This FDA certification represents not only technical recognition at the corporate level, but also marks a shift in China’s high-end medical equipment sector from “domestic substitution” to “global innovation.” As this technology accelerates its entry into international markets, Chinese medical devices are leveraging technological innovation to contribute “Chinese solutions” to the global prevention and treatment of cardiovascular diseases, driving a historic leap in the high-end medical equipment field from “following” to “running alongside and leading.”