波士顿科学首次获准在华本地生产医疗器械   2026-03-16

 

Boston Scientific, a major US medical technology company, has received Chinese regulatory approval to manufacture a medical device locally for the first time.

Boston Scientific has been cleared to produce the OptiCross HD, an intravascular ultrasound catheter, at its plant in Shanghai, the Massachusetts-based company said on March 13. The approval represents a key step in the firm’s localization strategy in China, said Zhang Jun, president of its China business.

The OptiCross HD can be used in conjunction with ultrasound to provide doctors with clear intravascular imaging and accurate measurement data for coronary angioplasty and stenting, helping them more thoroughly assess vascular lesions and optimize treatment strategies, the firm said.

China has about 330 million people with cardiovascular disease, including about 11.4 million with coronary heart disease, and that is climbing as the population ages, according to data disclosed by Boston Scientific. Angioplasty and stenting procedures for coronary heart disease are also increasing, reaching 1.9 million in 2023.

Boston Scientific hopes to make high-definition intravascular ultrasound diagnostic technology more accessible through localized production, helping more doctors to make treatment decisions with greater confidence in complex cases and thereby improve patients’ long-term outcomes, Zhang said.

As China’s healthcare market continues to expand, multinational medical device makers have been setting up local manufacturing facilities to meet growing demand. In 2024, Boston Scientific brought its first China plant online in the Lingang Special Area, a key policy-testing ground within the Shanghai Free Trade Zone, roughly a year after announcing the project.

The Lingang factory has China’s first automated production line for intravascular ultrasound catheters, with annual output capacity exceeding 10,000 units, Boston Scientific told Yicai. The plant has also turned out several product samples for regulatory inspection, including devices used to treat atrial fibrillation and benign prostatic hyperplasia, it added.

Boston Scientific plans to further expand local manufacturing and innovation, with the Lingang plant serving as a key operational hub, Zhang said. The company aims to work closely with Chinese clinical experts to advance precision diagnosis and treatment of cardiovascular diseases, helping more patients benefit from advanced medical technologies.

Source: Yicai Global

 

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