NMPA Approves Two Innovative Medical Devices; Sichuan Unveils Policies to Boost High-Quality Development of Biopharma and MedTech Industries

1. NMPA Approves Two Innovative Medical Devices for Market Launch

Recently, the National Medical Products Administration (NMPA) has approved the market entry of two innovative medical devices. One is the proton therapy system from Varian Particle Therapy System Co., Ltd. This product consists of an accelerator subsystem and a treatment subsystem. The accelerator subsystem includes the main accelerator system, energy selection system, and beam delivery system, while the treatment subsystem includes a 360° rotating beam treatment system and treatment planning system, applicable for treating systemic solid malignant tumors and specific benign diseases. The other is the implantable deep brain stimulation (DBS) pulse generator, implantable DBS electrode leads, and implantable DBS extension leads from Jingyu Medical Technology (Suzhou) Co., Ltd. When used together, the implantable DBS pulse generator, electrode leads, and extension leads form an implantable DBS system that stimulates the nucleus accumbens and anterior limb of the internal capsule, serving as an adjunctive treatment to prevent relapse in patients with refractory moderate to severe opioid addiction. (Every Day Economic News)

2. Sichuan Supports High-Quality Development of Biopharmaceuticals and Medical Devices Industry

Recently, Sichuan Province issued the "Several Policy Measures of Sichuan Province to Support the High-Quality Development of the Biopharmaceutical and Medical Device Industries," proposing 21 measures in seven areas. These aim to address issues such as long research and development cycles and difficulties in the transformation of achievements in the biopharmaceutical and medical device sectors, fostering an all-encompassing innovative ecosystem. Currently, Sichuan's biopharmaceutical and medical device manufacturing capacity ranks among the top in China, but it faces challenges such as slowing growth rates and inconsistent policies. The "Policy Measures" encourage universities, research institutes, and enterprises to jointly build pharmaceutical and device R&D platforms, support industrial infrastructure like experimental animal repositories in securing funding, establish a medical-engineering R&D consulting cooperation mechanism, and create a unified network for releasing R&D and transformation information. It also supports the establishment of innovative pharmaceutical and device achievement transformation and application centers at national medical centers, promoting the integration of artificial intelligence technologies throughout the entire innovative pharmaceutical and device R&D process. (Jintai News)

3. Xiaomi Collaborates with Brain-Computer Interface Companies Neutant and StairMed in Early Partnerships

Recently, the 2025 Xiaomi Human-Vehicle-Home Full Ecosystem Partners Conference is currently underway. Niu Kun, General Manager of Xiaomi's Core Systems Department, announced that Xiaomi has begun early-stage cooperation with a brain-computer interface company. According to reports, the brain-computer project will be integrated into MIJIA (Mi Home), allowing more people to use smart home devices without barriers. Additionally, from the official PPT presentation, Xiaomi’s brain-computer interface partners include NeuraMatrix and StairMed. Recently, NeuraMatrix successfully completed clinical trials on a fully implanted, wireless, battery-integrated brain-computer interface product independently developed by their team. The trial was conducted under the leadership of Professors Mao Ying and Chen Liang from Huashan Hospital Affiliated with Fudan University. Furthermore, in May this year, the prospective clinical trial of the invasive brain-computer interface system carried out by Shanghai StairMed Technology Co., Ltd. proceeded smoothly. (IT Home)

4. Beijing Calls for 2026 Brain-Computer Interface Reserve Research Projects

Recently, in order to implement the requirements of the "Action Plan for Accelerating the Innovative Development of Brain-Computer Interface in Beijing (2025-2030)", Beijing has solicited reserve projects in the brain-computer interface field for the year 2026. The solicitation directions include: innovative product development, including semi-invasive and invasive products, with core parameters required to reach leading levels, completing R&D testing and clinical trials; non-invasive products, which must complete R&D with leading parameters and achieve scaled promotion; auxiliary equipment, which needs to complete R&D with parameters meeting standards to support improved system integration; multi-application scenario validation, expanding product applications in typical scenarios such as medical treatment, health care, industrial safety, education and sports, and smart living, focusing on at least one scenario to complete adaptation, validation, and pilot implementation, forming an evaluation report, and building a replicable and promotable business model. (Brain-Computer Interface Community)

5. Hainan Wholly Foreign-Owned Hospital Unveiled

Recently, Boao Fulong Hospital, a wholly foreign-owned hospital in Hainan operated by Singapore's Fulong Group, was inaugurated in Haikou and is located in the Lecheng Pilot Zone. Leveraging Lecheng's special policy, Fulong Group has introduced advanced medical technologies and products to provide high-end longevity tech medical services. It also plans to build cell laboratories in Hainan, positioning the province as an important gateway connecting regional markets. Fu Sheng, Director of the Lecheng Pilot Zone Administration, stated that they will utilize the pilot advantages to create a "core hub" for global medical technology transfer and a "Hainan model" for international medical openness and cooperation. He expressed hope that Fulong Group would deeply integrate with policies to deliver world-class diagnostic and treatment services. (Sina)

6. AI Turns ECG into 3D Heart Map

Recently, the U.S. FDA approved the new generation vMap cardiac mapping software from Vektor Medical in San Diego. This software uses AI to convert routine 12-lead ECGs into 3D cardiac maps. The core upgrade highlights include three features: the addition of atrial flutter mapping functionality, support for direct streaming of ECG and data; support for local and remote connections, solving the "data silo" pain point; becoming a "medical software as a device," reducing the cost of popularization. The CEO of Vektor Medical stated that this approval is an important milestone for the product’s capabilities, which can improve the efficiency of physicians. The upgraded vMap software will be rolled out to U.S. users in the coming months. Experts from the University of Pennsylvania noted that it can better integrate into the electrophysiology diagnosis and treatment ecosystem, streamline processes, and benefit more doctors and patients. In recent years, AI + 3D cardiac diagnosis and treatment technology has been accelerating its implementation. (CCI Cardiovascular Physicians Innovation Club)

7. R&D Design Services Accelerate the Clinical Translation of Medical Research Achievements

The research and development of medical devices is a complex and rigorous process involving multiple aspects such as technology, regulations, and clinical practices. StairMed has a 20,000-square-meter science and innovation center and has established a Medical Device Research Institute dedicated to the clinical transformation of medical research achievements. It boasts a high-level, international, multidisciplinary professional team proficient in the entire process of R&D, regulations, clinical trials, registration, and production, capable of developing and producing various complex innovative products. With extensive project experience and industry resources, it has built a standardized, regulated, and digitalized full-process service system. It provides one-stop services from preliminary market research, product concept generation, product design and development to prototype production and testing. To date, StairMed has had over 200 projects enter the review stage, with more than 100 projects currently under development, achieving a 100% success rate in transformation. (Compiled by StairMed)

8. StairMed Completes Tens of Millions of Yuan in Series A Financing

Recently, Minimally Invasive Medical Technology (Hangzhou) Co., Ltd. announced the completion of a multi-million yuan Series A round of financing. This round of investment was led by Hetang Ventures, with follow-up investments from existing shareholder Taiyu Investment, and Hanyu Capital serving as the exclusive financial advisor. This marks another significant capital injection for Minimally Invasive following its angel round funding from PuHua Capital in 2023, and its Pre-A round funding from Taiyu Investment, Guochuang QinZhi, and Huagai Capital in 2024. Founded in 2021, Minimally Invasive has been committed to addressing clinical pain points in vascular diseases, focusing on the golden track of active energy vascular intervention. Since its establishment, Minimally Invasive Medical has fully utilized industry advantages, gathering professional expertise from both China and Germany, establishing production bases and R&D offices in Hangzhou, Shenzhen, and Coburg, Germany, thereby building a global operational network. (Vcbeat)