Home Weekly Medical Device News Roundup [Apr 28 – May 4, 2026]: Funding, Approvals, and Strategic Expansions

Weekly Medical Device News Roundup [Apr 28 – May 4, 2026]: Funding, Approvals, and Strategic Expansions

May 06, 2025 08:03 CST Updated 08:03
Kossel

Vascular Interventional Device Manufacturer and R&D Developer

Core Medical

Artificial Heart Series Product Developer

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01


Intuitive Medical Expands Its Presence in the Asia-Pacific Region

Recently, Intuitive Surgical announced a $10 million (approximately 73 million RMB) investment in its robotics hub located in Seoul, South Korea. The company plans to create 100 new jobs over the next five years. The surgical robotics center established by the company in South Korea has been actively involved in the development and promotion of robotic surgery technologies. According to the plan, the 100 new positions will cover various fields such as R&D, sales, marketing, and customer service, while also collaborating with local universities in South Korea to promote the adoption and cooperation of surgical robots. Intuitive Surgical’s strategic layout in the Asia-Pacific region includes establishing a production and R&D center in Shanghai, China, and setting up an innovation center for surgical robotics in Seoul, South Korea.

02


Keyue Medical (Suzhou) Co., Ltd Completes Tens of Millions of Yuan in FinancingPre-A Round Financing

Recently, Keyue Medical (Suzhou) Co., Ltd. ("Keyue Medical" for short) has completed a Pre-A round of financing worth tens of millions of yuan. This round of financing was led by Harvest Fenghou Ai and Yisheng Phase I Fund, with follow-up investments from Sichuan Zhengheshuang Fund and others. The funds from this round of financing will be mainly used for product development, clinical trials, and market expansion of non-invasive neuromodulation devices. Keyue Medical is the first in China to develop and launch a non-invasive vagus nerve stimulation system, innovatively proposing an integrated intelligent diagnosis and treatment solution with dual functions of neural stimulation and physiological assessment. Through individualized resonance breathing-guided vagus nerve stimulation, combined with an individualized vagus nerve stimulation parameter library constructed by a feature modeling system based on big data of sleep EEG and ECG, it achieves personalized, precise, and digital treatment methods while making the entire treatment process evaluable and controllable. It has successively launched several products, including transcutaneous low-frequency vagus nerve stimulators, transcranial microcurrent stimulators, transcranial direct current stimulators, transcranial magnetic stimulators, polysomnography equipment, and automatic analysis software for sleep EEG data.

03


Kossel Medtech Completes Nearly 100 Million YuanSeries B+ Financing

Recently, Kossel Medtech (Suzhou) Co., Ltd. announced the completion of a nearly 100-million-yuan B+ round of financing. This round of financing was led by Tie Tou Ju Shi, a well-known investment institution in China, with continued additional investment from SND Finance Control and participation from Yuan Yong Investment. The funds will be used for core product research and development, global market promotion, and production capacity expansion. This round of financing demonstrates investors' full recognition of Kossel's rapid and high-quality development and future potential, and lays a solid foundation for Kossel to consolidate its platform-based layout. Established in 2013, Kossel has become a platform enterprise in the field of vascular interventional devices, forming a "one core, three wings" business layout: the parent company builds a "one-stop" treatment system for peripheral intervention (covering venous/arterial), subsidiary Haiyu Xincheng focuses on the cardiac electrophysiology field (providing comprehensive solutions for the treatment of tachyarrhythmia), subsidiary Mixin Medical focuses on the research and development of coronary intervention products and overseas technology transfer, and subsidiary Haiwang Medical is committed to breaking through the "bottleneck" technology of medical core raw materials.

04


Core Medical Completes Over$100 Million Series D Financing

Recently, Core Medical successfully secured over US$100 million in its Series D financing round, thanks to its innovative strength and technical accumulation in the artificial heart field. This round of financing was jointly led by Loyal Valley Capital, the Zhongguancun Independent Innovation Special Fund of the Social Security Fund (managed by Legend Capital), Prosperity7 Ventures (P7) under Aramco Ventures, Cornerstone Capital, and a well-known industry investor. Delian Capital and New Alliance Capital also participated as follow-up investors. Since its establishment in 2016, Core Medical has continuously led innovation in the artificial heart sector. Its self-developed Corheart®6 Implantable Ventricular Assist System (LVAD), DuoCor® Integrated Full Magnetic Levitation Biventricular Assist System (BIVAD), and CorVad® Interventional Ventricular Assist System (PVAD) have all successively passed the NMPA Innovative Medical Device Special Review Process application, entering the "green channel." This not only accelerates the product's market entry but also further enhances its competitive edge.


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05


"Pre-mounted Dry Valve" Heart Valve Approved for Marketing

Recently, according to the "Chengdu Release," the PROSTYLE A Transcatheter Aortic Valve System, co-developed by Professor Chen Mao and Professor Peng Yong's team from the Cardiology Department of West China Hospital, Sichuan University, along with alumnus Dr. Zhong Shengping, has been approved for marketing by the National Medical Products Administration. This product is a pre-assembled TAVR dry valve aortic valve system, suitable for symptomatic severe aortic stenosis patients, and falls under the category of innovative products in China. Compared with traditional products, this innovative valve is preserved in a dry state, eliminating the need for glutaraldehyde solution storage, reducing the risk of glutaraldehyde residue, enhancing biocompatibility, slowing down the calcification process of the valve, and extending its service life. Additionally, the pre-assembled design simplifies the complex clinical preparation work during implantation, ensures consistent and controllable quality of the pre-assembled valve, further reduces product risks, and enhances clinical patient benefits.

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06


Enhanced Coating Artificial Ligament Approved as Innovative Medical Device

Recently, the National Medical Products Administration approved the innovative product registration application for "Artificial Ligament" (Registration No. 20253130733) from Beijing Wanjie Tianyuan Medical Device Co., Ltd. The product utilizes surface modification technology, grafting a sodium polystyrene sulfonate hydrophilic coating on the portion of the artificial ligament that contacts soft tissue, and applying a hydroxyapatite coating through a mineralization process on the portion that contacts the bone tunnel, providing excellent fixation after implantation. The product is used in conjunction with the company’s non-absorbable ligament fixation screws and is suitable for compensating or reinforcing damaged knee cruciate ligaments. WJ SUPERLIG® Artificial Ligament has completed clinical trials at several top-tier tertiary hospitals in China, with the first batch of indications including complex surgeries such as anterior and posterior cruciate ligament reconstruction and knee collateral ligament reconstruction. In the future, the product will gradually expand to repair applications in multiple areas such as acromioclavicular ligaments and foot and ankle ligaments, benefiting more patients.

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07


Absorbable Large-Bore Vascular Closure Device Approved for Marketing

Recently,Vivasure Medical Announces CE Mark Approval for Its Absorbable Large-Bore Vascular Closure Device, PerQseal Elite, in Europe. PerQseal Elite, based on Vivasure's PerQseal technology platform, is specifically designed for large-bore vascular closure following cardiovascular interventional procedures such as TAVR and EVAR, offering an innovative solution that requires no sutures and is fully absorbable. Prior to the launch of PerQseal Elite, there were no other fully bioabsorbable large-bore closure devices available on the market. Additionally, unlike existing vascular closure devices, PerQseal Elite requires no pre-procedural preparation steps, further streamlining the surgical process. Implanted intravascularly, PerQseal Elite is simpler and more controllable compared to traditional closure techniques, allowing the vessel to return to its natural state by avoiding the presence of foreign materials such as collagen, metal implants, or sutures.


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08


Antu Full Power

Recently, the Antu Biochannel Partner Conference themed "Gathering Momentum for Win-Win Cooperation · Embarking on a New Journey" was grandly held in Zhengzhou. Partners from all over China gathered to discuss cutting-edge technologies and cooperation opportunities in the field of infectious disease testing. Antu Biotech launched an automated microbial sample pre-processing system that efficiently handles 70%-80% of routine specimen inoculations, covering various types such as sputum, swabs, and urine. The system ensures biosafety through standardized operation processes and significantly improves laboratory efficiency while reducing labor costs. The intelligent microbial blood culture solution achieves critical value alerts through smart monitoring, reducing average machine delay time by 10 hours and greatly improving pathogen detection rates in blood samples. It solves the issue of delayed submission during non-working hours without requiring night shifts in microbiology labs. Innovative configurations like solid-state lasers and reverse acceleration enable intelligent mass spectrometry technology to achieve second-level precise pathogen identification, breaking through traditional mass spectrometry detection bottlenecks. The next-generation fully automatic identification and susceptibility analysis system rivals international advanced standards, covering full-scenario detection of bacteria and fungi, ensuring rapid and comprehensive drug sensitivity reports, providing reliable basis for precise clinical medication.

09


HKUST Develops Multiple Smart Medical Devices

Recently, a team led by Associate Professor Shen Yajing from the Department of Electronic and Computer Engineering at the Hong Kong University of Science and Technology (HKUST) successfully integrated artificial intelligence and robotics to develop three groundbreaking smart medical devices. These devices are designed for diagnostic monitoring, surgical assistance, and post-operative rehabilitation, aiming to help doctors address current challenges in diagnosis and treatment, optimize procedures, and improve efficiency, thereby promoting the development of smart healthcare. The team is actively exploring collaborations with public and private institutions, industries, and investors to advance the clinical application and implementation of these projects. Professor Shen's team has developed an AI hand tactile interaction system called PhyTac. This cone-shaped device is equipped with up to 368 sensing units that precisely correspond to various pressure points on the hand. By simply gripping the device and exerting force, patients allow doctors to instantly map the corresponding pressure points on the hand within the AI system. This helps doctors quickly monitor the patient’s rehabilitation progress and can be combined with VR technology to design games for patients to perform rehabilitation training using the device, enabling the formulation of appropriate rehabilitation plans.

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10


Vending Machines for Medical Devices Officially Launched in Guilin City

Recently, the automatic vending machines for medical devices in Guilin City that comply with management regulations have been successfully registered and officially put into use in Longsheng Autonomous County. These machines now have legitimate "identification," providing assurance to both businesses and the public. In February this year, the Guangxi Drug Administration issued the "Guangxi Regulations on the Supervision and Management of Automatic Vending Machines for Medical Devices (Trial)," which clarified the requirements for medical device operating enterprises using automatic vending machines for retail sales. This signifies that automatic vending machines will become a "formal force" in the field of medical device retail in Guangxi. Following the issuance of these regulations, the medical device regulatory department in Guilin City promptly communicated the relevant requirements to enterprises and guided them through the necessary registration procedures. Longsheng County's Binyuan Pharmacy had long planned to install an automatic vending machine, and with clear guidelines now in place, the company seized the opportunity to submit an application for a change in business premises, adding a location for the automatic vending machine. It has since become the first enterprise in Guilin City to possess an automatic vending machine that complies with management regulations.

11


600 Million Medical Devices Procurement Rolls Out Nationwide in China

Recently, the Health Commission of the Xinjiang Uygur Autonomous Region released the "Detailed Information on the Renewal Project of Medical Equipment for County Medical Consortia," with a budget of 600 million yuan. A total of 1,777 units (sets) of equipment are planned for renewal, mainly including medical imaging, radiotherapy, and clinical laboratory equipment. Requirements to be met: covering 14 regions (prefectures and cities) in the Xinjiang Uygur Autonomous Region. Since April, provinces such as Hubei, Henan, Hunan, Hebei, Ningxia, and Sichuan have successively initiated bidding processes for the renewal of county-level medical equipment, with the total budget exceeding 2 billion yuan. According to the latest data from the National Health Commission, as of the end of 2021, China had a total of 17,294 county-level hospitals. Under the "Thousand Counties Project" plan by the National Health Commission in 2022, by 2025, at least 1,000 county hospitals in China are expected to reach the service capability level of tertiary hospitals. The continuous signals from the state indicate that national support for enhancing the capabilities of county-level hospitals has reached a new height, and nearly 17,300 county-level hospitals will undergo comprehensive upgrades.

12


NMPA Intelligent Medical Device Research and Evaluation Laboratory Launched

Recently, the In-depth Integration of Artificial Intelligence in Biomedicine and the Promotion Conference for Suzhou's AI-driven Medical Device Industry Development was held in Suzhou. At the event, the National Medical Products Administration (NMPA) Key Laboratory for Research and Evaluation of Intelligent Medical Devices was officially launched and located at the Jiangsu Medical Device Science and Technology Park. The open-call for research topics from the laboratory also commenced simultaneously. This laboratory will focus on innovation in intelligent medical device R&D and enhancement of regulatory capabilities. It aims to develop new tools, methods, standards, and systems for regulating innovative medical devices, addressing key challenges across all links in the industry chain, and promoting the transformation and application of innovative achievements. Additionally, a sub-fund invested by the Jiangsu Provincial Strategic Emerging Industry Mother Fund was announced. The fund has a planned total scale of 1 billion yuan and prioritizes investments in large health industry sectors such as medical devices, biomedicine, and medical services, targeting early-stage and growth-phase projects with high technical barriers and strong commercial prospects.

13


Wenzhou Medical Imaging Smart Brain Platform Wins Another National Award

Recently, the Medical Industry Digital Ecosystem Innovation Conference and the 7th Intelligent Healthcare Innovation Competition National Finals, themed "Empowerment through Computing, Innovative Healthcare," were successfully held. The Wenzhou Medical Imaging Brain Platform, submitted by the Wenzhou Health Information Center, advanced to the national finals after being selected in the provincial division (only 5 projects in Zhejiang Province were chosen) and won the third prize in the national finals' technology innovation track. The Medical Imaging Brain Platform is an imaging artificial intelligence technology application cluster platform developed mainly using medical AI technology in Wenzhou. It has completed the deployment of 12 medical AI technologies, covering all public medical institutions in the city, and has provided more than 12.7 million instances of intelligent imaging analysis. Through AI technology, it effectively alleviates issues such as insufficient medical technical capabilities and shortages of medical personnel in remote areas, improving the standardization of regional healthcare.

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14


NMPA Cancels Registration of Electronic Gastroscope and Others10 Medical Device Registration Certificates

Recently, the National Medical Products Administration announced the cancellation of registration certificates for 10 medical devices, including electronic gastroscopes. According to the Regulations on the Supervision and Administration of Medical Devices and based on corporate applications, the National Medical Products Administration has canceled the medical device registration certificates for 10 products from five companies. The 10 products are as follows: electronic gastroscope, ultrasound and electrotherapy apparatus, ultrasound therapy apparatus, shortwave therapy apparatus, traction apparatus, dry salt aerosol therapy apparatus, closed urine meter UnoMeterTMSafetiTMPlus, closed small-scale urine meter and intra-abdominal pressure monitoring device UnoMeterTMAbdoPressureTMKit, and disposable intravenous indwelling needle.

15


NMPA Releases "Quality Management Standards for Medical Device Online Sales"

Recently, in order to standardize the online sales behavior of medical devices and ensure public safety in the use of medical equipment, the National Medical Products Administration officially released the "Quality Management Standard for Online Sales of Medical Devices." This Standard will come into effect on October 1, 2025, setting clear requirements in aspects such as qualification review, information display, and risk control, further reinforcing the main responsibilities of online medical device sales enterprises and e-commerce platforms, and promoting high-quality development within the industry. The key measures of the newly released Standard focus on qualifications and information transparency: online sales enterprises must prominently display their business licenses, filing certificates, and other qualification information on the homepage of their websites continuously, and indicate critical information such as the medical device registration certificate number, indications, contraindications, etc., on product pages. For fitting products (such as contact lenses and hearing aids), warning phrases like "Professional fitting required" must be marked. E-commerce platforms are required to strictly review the qualifications of enterprises applying to join the platform, dynamically update records, and verify them every six months.

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16


Tianjin Supports the High-Quality Development of Technology-Based Enterprises

Recently, in order to further strengthen the position of enterprises as the main players in scientific and technological innovation, promote the deep integration of scientific and technological innovation and industrial innovation, and accelerate the cultivation and development of new productive forces, Tianjin has formulated the following policies and measures to strongly support the construction of a technology-strong city. For innovative pharmaceuticals and medical devices, support will be provided for key technology research and development such as novel drug discovery, drug delivery, brain-computer interfaces, and gene sequencing, with a maximum project support of 2 million yuan from the municipal financial funds; for biomanufacturing, support will be provided for key technology research and development such as core strain creation, enzyme engineering, and gene editing, with a maximum project support of 10 million yuan from the municipal financial funds. For innovative pharmaceuticals and medical devices, support will be provided for drug clinical trials, generic drug consistency evaluations, and secondary development of major traditional Chinese medicine varieties, with a maximum project support of 15 million yuan from the municipal financial funds; support will be provided for innovative R&D and clinical application of medical devices, with a maximum project support of 5 million yuan from the municipal financial funds; support will be provided for medical institutions to enhance their clinical trial capabilities, with a maximum project support of 2 million yuan from the municipal financial funds; support will be provided for post-marketing evaluation research of pharmaceutical and medical device products, with a maximum project support of 2 million yuan from the municipal financial funds.

17


Artificial Heart, etc.Six Categories of New Medical Technology Projects Reduce Patients' Economic Burden

Recently, the National Healthcare Security Administration held a special sharing session on "Healthcare Departments Boosting Scientific Innovation," showcasing significant achievements in innovation leadership and collaborative support. The meeting highlighted the promotion of cutting-edge medical technologies such as artificial hearts, brain-computer interfaces, and cochlear implants through the introduction of six new categories of medical service pricing projects, bringing new hope to patients. As an important treatment for end-stage heart failure patients, the high cost of artificial heart therapy was once a major barrier to its widespread adoption. The National Healthcare Security Administration addressed the charging issues related to the implantation, removal, and postoperative adjustment of artificial hearts by uniformly establishing new price items in the cardiovascular project guidelines, including fees for auxiliary device implantation, removal, and equipment costs. Through communication with five listed companies approved in China, guiding enterprises to reduce excessive markups in intermediate distribution links, the overall cost of artificial heart implant surgery has been reduced from millions of yuan to around 700,000 yuan. Aerospace Heart Technology Co., Ltd. took the lead in proactively reducing prices to 499,000 yuan per set, further enhancing the feasibility of artificial heart implant treatments.

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18


Beijing E-Town Biopharmaceutical Industry Chain Support System Implemented

Recently, at the Beijing Yizhuang Innovation Release Conference, the Economic and Technological Development Zone (ETDZ) announced a package of policies. Among them, the "Several Opinions of Beijing Economic and Technological Development Zone on Promoting the High-Quality Development of the Pharmaceutical and Health Industry" was released. It is expected that by 2027, the industrial output value of the pharmaceutical and health industry in the ETDZ will exceed 120 billion yuan, with more than 25 innovative drugs and medical devices approved for marketing. Specifically, in terms of promoting the integrated development of scientific and technological innovation and industrial innovation, it closely aligns with national strategies, focusing on the layout of regenerative medicine,In future health fields such as brain science and computational biology, support breakthroughs in cutting-edge sectors like cell and gene therapy (CGT) and high-end medical equipment. Fully upgrade support for the pharmaceuticals and healthcare sector: provide rewards of 10 million yuan for Phase II clinical trials and 30 million yuan for Phase III clinical trials of Class 1 innovative drugs (up to 40 million yuan for cell and gene therapy drugs); clear support is also given to veterinary drugs and medical devices. The "Opinions" also open up 100 high-quality medical datasets, accompanied by a data voucher mechanism, to promote the deep integration of "large models + pharmaceutical R&D" and accelerate the development of emerging fields such as computational biology.

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19


A Hundred-Billion-Level Medical Device Industry Cluster Lands in Zhengzhou High-Tech Zone

Recently, the reporter learned fromOn April 25, at the 2025 Zhengzhou High-Tech Healthcare Industry High-Quality Development Conference, the industrial ecosystem plan for the "Zhengzhou High-Tech MedPark·Medical Device Industrial Park" was announced. The plan aims to create a hundred-billion-level medical device industry cluster in the Central Plains region through three years of development. As a benchmark project for the medical device industry in Henan Province and a key-supported park by the provincial government, the park covers an area of 500 mu with a total investment exceeding 5 billion yuan. It focuses on three main directions: digital healthcare, high-end consumables, and intelligent equipment. It is expected to attract over 200 companies, with an annual output value surpassing 10 billion yuan. The first phase is scheduled for completion and operation by 2025. The park will also feature supporting facilities such as a scientific research transformation platform, a financial services hub, and a smart logistics and warehousing system, forming a closed-loop integration of "R&D—pilot testing—production—sales."

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Note: The information in this article is compiled based on online news.

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