Medtronic's NuPace™ Pacemakers 'Made in Shanghai' Roll Out Nationwide from Lingang

Intern reporter of The Paper, Liu Lingguo

Xinhui News Editor Xie Xin

The Localization of High-End Medical Devices in Shanghai is Moving from Project Implementation to Clinical Application.

Journalists from The Paper learned from Medtronic that, as of April 2026, the NuPace™ series of pacemakers produced in China have successfully completed clinical implants in a total of seven hospitals across provinces such as Beijing, Xinjiang, Zhejiang, Jiangsu, and Tianjin. This means that this pacemaker, which was locally developed and manufactured in Shanghai, has moved from the registration approval stage to real-world clinical application, providing a new treatment option for patients with bradycardia.

In December 2025, the NuPace™ series of implantable cardiac pacemakers, developed and manufactured by Mai'an Medical Technology (Shanghai) Co., Ltd., a wholly-owned subsidiary of Medtronic, officially received market registration approval in China. The accompanying active leads, passive leads, and cardiac rhythm management device programmer software were also successively approved for marketing in early 2026.

NuPace™ Series Implantable Cardiac Pacemaker

According to Medtronic, the NuPace™ series of implantable cardiac pacemakers are mainly used for the treatment of bradycardia, covering both single-chamber and dual-chamber implantable cardiac pacemakers. According to company data, this series of products features an ultra-long service life, automatic threshold management, sensing protection, minimized right ventricular pacing, and other functions, ensuring long-term stable pacing therapy, reducing the risk of patients developing persistent atrial fibrillation in the long term, and also providing early warning capabilities for heart failure. The pacemakers and accompanying leads are equipped with Medtronic's SureScan MRI-compatible technology, supporting 3.0T MRI scans, addressing the issue where patients with traditional pacemakers cannot undergo MRI examinations.

From the perspective of product layout, as cardiac pacemakers, pacing leads, and dedicated programmer software have been successively approved, the products implemented in hospitals are no longer single-device applications but form a complete, closed-loop clinical diagnosis and treatment system. Medtronic told the media that the NuPace™ series has a multi-model layout tailored to meet domestic clinical diagnosis and treatment needs, adapting to clinical surgical operations and long-term chronic disease management for patients. For implantable cardiovascular devices, having the entire chain of products approved can enhance postoperative programming, outpatient follow-up, and full life-cycle patient management capabilities beyond just device implantation.

This product has gained attention because it is a high-end implantable device that has been locally researched, developed, and produced in Shanghai. Data shows that Medtronic (Shanghai) Limited, established in 2021, is headquartered in "Life Blue Bay" of the Lingang Special Area of the China (Shanghai) Pilot Free Trade Zone, as a wholly-owned subsidiary of Medtronic. In 2021, Medtronic signed an investment agreement with the Lingang Special Area to promote the project's implementation. Medtronic stated that Medtronic (Shanghai) Limited covers R&D, production, sales, innovation incubation, digital operations, and customer service.

From the project timeline, Shanghai's role is relatively clear. Medtronic introduced that since the signing and settlement of Mai An in Life Blue Bay in 2021, it took 16 months to complete the factory delivery, and within 1 year to complete the production line construction, verification and debugging. By the end of 2025, the first NuPace™ series product will obtain the registration certificate and go on the market, and by 2026, the product will enter the operating rooms of hospitals in many places. For high-end implantable devices, several key steps from R&D, production, registration to clinical application have already been completed.Shanghai LingangAchieve connection.

During the project advancement, Shanghai has taken on more than just the production环节. In response to an interview with The Paper, Medtronic stated that the Lingang Special Area Management Committee and "Life Blue Bay" have provided support in terms of approval, supply chain, and industrial collaboration. In the product approval process, the market launch of Mai'an products has been listed as a key project by the municipal drug regulatory department. The park has set up a dedicated service team to guide registration and quality system establishment, helping to shorten the approval cycle. In terms of supply chain assurance, the High-Tech Department and the Comprehensive Bonded Area Department of the Lingang Special Area Management Committee have opened a customs green channel to solve the problem of customs clearance for core raw material imports. In terms of industrial collaboration, the park has promoted strategic cooperation between Mai'an and high-quality enterprises within the park by relying on the Medical Device Marketing Authorization Holder system.

Medtronic told Interface News that after the NuPace™ series achieves research and production in Shanghai Lingang, the supply, emergency response, and clinical support of the products will be closer to the Chinese market. As the pacemaker body and its accompanying electrodes and programmers are successively approved and enter clinical application, patients will also receive more comprehensive localized support in postoperative programming, follow-up visits, long-term management, and other aspects.

Medtronic believes that the significance of the Maian project lies not only in the addition of a production line but also in the localization of mature technical systems, quality standards, and product capabilities in Shanghai. This initiative aims to advance research, manufacturing, and clinical applications in collaboration with local medical institutions, universities, research institutes, and industry chain partners. In the industrial context of Lingang, such projects demonstrate that some key capabilities in the high-end medical device sector—from research and manufacturing to clinical application—are gradually taking root locally.

This is not the only case of Shanghai promoting the local manufacturing of foreign-invested biopharmaceuticals and medical devices. In March this year, AstraZeneca announced the construction of a cell therapy commercial production and supply base in "Life Blue Bay," Lingang. Boston Scientific's disposable intravascular ultrasound diagnostic catheter, OptiCross HD, also received formal approval from the National Medical Products Administration in the same month and will achieve localized production in Lingang. Lingang is now handling more than just traditional manufacturing; it is expanding into higher-technical-threshold fields such as cell therapy and high-end interventional devices.