Medical Device Weekly Roundup (June 15–21, 2026): Funding, Approvals, and Strategic Collaborations

On June 14, 2026, Baiyang Pharmaceutical Group and Jinan Junxin Cancer Hospital signed a strategic cooperation agreement. The two parties will jointly establish a Precision Radiosurgery Treatment Center centered around the ZAP-X® Mars Rover Radiosurgery Robot (hereinafter referred to as “ZAP-X”). This move marks a new phase of regional expansion and scaled-up clinical application of ZAP-X in China. As an advanced radiosurgery treatment device, the establishment of ZAP-X treatment centers will provide more precise and efficient radiosurgery services to cancer patients in the region. Currently, the ZAP-X radiosurgery treatment centers at Xuanwu Hospital of Capital Medical University and Peking University International Hospital have completed initial installation and are poised to commence clinical applications or related research.

Recently, Taimei Medical Technology and Shanghai United Imaging Healthcare High-Tech Research Institute have entered into a strategic partnership to jointly develop an AI-driven comprehensive solution for imaging endpoint assessment services. This collaboration aims to accelerate the clinical development of innovative pharmaceuticals and medical devices, thereby extending the benefits of these advancements to more patients. As the core R&D institution of the United Imaging Group, the United Imaging Research Institute has leveraged group resources to build a specialized and standardized medical imaging clinical research service system through its imaging CRO platform. Its services cover multiple disease areas and the entire lifecycle of drug and device development, offering customized, one-stop medical imaging solutions. As a leading domestic AI-powered clinical development platform, Taimei Medical Technology has cultivated deep expertise in imaging endpoint assessment services for many years. It has accumulated over 500 served projects and facilitated the market approval of more than 60 projects. In 2025, Taimei provided full or partial support for 60% of Class 1 innovative drugs approved in China. Furthermore, the company has pioneered the transition toward value-based multidisciplinary imaging assessment.

In June 2026, the Easybridge™ Endovascular Reconstruction System for Type A Aortic Dissection, independently developed by Chuangxin Medical, was successfully selected for the European Medicines Agency’s Pilot Program on Breakthrough Medical Devices. It is recognized as one of the “original Chinese” solutions in the field of minimally invasive treatment for the ascending aorta and stands among the first batch of Chinese cardiovascular innovative devices to be included in the program. This selection underscores the original innovation capabilities of China’s high-end medical devices in the field of aortic intervention, marking a leap from “technological following” to “original leadership.” During the application process, Chuangxin Medical collaborated closely with Xiyi Medicine, demonstrating the professional depth of Chinese CROs in facilitating global market access for complex innovative products. Type A aortic dissection is a life-threatening cardiovascular emergency, and traditional open-chest surgery has its limitations. The Easybridge™ system was specifically designed to address this clinical pain point, employing a modular design that balances perfusion requirements to achieve “precise reconstruction of the ascending aorta.”

From June 11 to 14, 2026, the 20th Annual Meeting of APSCVIR was held in Suzhou, serving as a key academic platform for interventional radiology in the Asia-Pacific region. Ganaiwei showcased its CT-guided puncture navigation system, Irreversible Electroporation (IRE) ablation system, Radiofrequency Ablation (RFA) system for tumors, radiofrequency venous closure system, and a full range of biopsy and guidewire products, demonstrating its product portfolio and clinical solution capabilities in the field of image-guided precision intervention. Centering on image-guided interventional therapy, Ganaiwei has constructed an integrated solution framework encompassing “puncture–diagnosis–treatment,” with each product playing a distinct role. During the conference, Ganaiwei engaged in in-depth exchanges with experts from multiple countries, drawing significant attention to its CT-guided puncture navigation system and IRE non-thermal ablation technology. With the advancement of interventional radiology, Ganaiwei will continue to deepen its expertise in the field of precision intervention, promote technological innovation, and explore the boundaries of clinical value.

On June 16, 2026, Nervonik, a clinical-stage medical device company developing next-generation peripheral nerve stimulation (PNS) technology, announced today the completion of its first-in-human feasibility study. The study demonstrated the ability to record key nerve-related biosignals from 16 peripheral nerves in eight patients with chronic pain, across multiple anatomical targets. The study was conducted in collaboration with physicians at Punta Pacifica Hospital in Panama City, Panama. Timothy Deer, M.D., President and CEO of the Virginia Spine and Nerve Center, implanted the neurostimulation leads in patients with chronic pain. Leveraging Nervonik’s technology, the system was able to record evoked compound action potentials (ECAPs—the electrical signals generated by nerves in response to stimulation) as well as myoelectric potentials. These signals serve as important biomarkers for therapy delivery and will support the future development of artificial intelligence- and biosensing-based functionalities for Nervonik’s peripheral nerve stimulation platform.

Recently, the Beijing Municipal Committee of the Chinese People's Political Consultative Conference (CPPCC) held a special deliberative standing committee meeting, where members and experts offered recommendations for the innovative development of the medical device industry. Beijing has achieved remarkable results in the field of innovative medical devices. Yao Weihai suggested strengthening medical-engineering collaboration by establishing a “clinical co-designer” system to involve physicians in research and development, with pilot implementations in municipal and research-oriented hospitals. Ma Chunxiu stated that patient capital support is crucial during the critical period of industrial transformation. She recommended coordinating funds to optimize investment mechanisms, focusing on key sectors, piloting the establishment of advanced clinical evaluation centers, and expanding the scope of medical insurance pilots to promote product adoption. Ou Yunsong suggested addressing the “last mile” challenge for the hospital adoption of innovative devices by innovating procurement models to alleviate financial pressure, improving medical insurance pricing, and accelerating a smooth transition in medical insurance price policies to ensure patients have access to these technologies.

Thailand’s Ministry of Public Health Adjusts Labeling and Instructions for Use Requirements for Medical Devices; New Regulations Take Effect on June 20, 2026Recently, Thailand’s Ministry of Public Health adjusted the rules governing the labeling and instructions for use (IFU) of medical devices, with the new regulations officially taking effect on June 20, 2026. The new rules mandate that manufacturers and importers of medical devices must provide products with clear, legible labels and comprehensive IFUs, strictly prohibiting false or exaggerated claims. For medical devices intended for use by the general public, labels and IFUs must be provided in Thai. For professional devices intended for use by healthcare professionals, labels and IFUs may be provided in either Thai or English. The new regulations support electronic IFUs, such as providing detailed information via QR code scanning, and have established specific guidance for software-based devices, mobile applications, and dental devices. Labels produced in accordance with the previous regulations prior to the effective date may continue to be used for no more than two years from the date the new rules take effect. As regulatory barriers for imported medical devices continue to rise in global markets, Chinese companies expanding overseas must carefully navigate and comply with the specific regulations of each target market.