Weekly Highlights of Medical Device Industry (Aug 12–18, 2024): Innovations, Approvals, and Funding Milestones
Sirrem
Intelligent Rehabilitation Robot Technology R&D Provider
ShineyoMedical
Provider of Atrial Fibrillation Electrophysiology and Peripheral Vascular Intervention Solutions
SyMap
Innovative Device R&D Manufacturer in Cardiovascular and Respiratory Fields
01
Sirrem, a Chinese Soft Rehabilitation Robot Developer, Completes Tens of Millions in Pre-A Funding to Accelerate Full-Cycle, Multi-Scenario Rehabilitation Solutions
On August 13, 2024, Ningbo Sirrem Medical Technology Co., Ltd. announced the completion of a multi-million yuan Pre-A round of financing. This round of financing was jointly invested by Ningbo Fuchuang Venture Capital Fund and Ningbo Angel Fund. Sirrem Medical, established in 2019, has been deeply engaged in the field of rehabilitation technology. Relying on the Rehabilitation Robotics Transformation Platform of Shanghai Jiao Tong University, the company is committed to the research and development of rehabilitation robot technology, creating a series of soft rehabilitation robot products to help patients achieve better rehabilitation, improve their quality of life, and regain new life. The company's products have more than forty patents and have obtained medical device registration certificates from China's NMPA, the European Union's CE, and the U.S. FDA.
02
ShineyoMedical Completes Nearly 100 Million Yuan in Series A+ Financing, Accelerating the Launch of Cardiac Electrophysiology and Peripheral Vascular Intervention Products
On August 12, 2024, ShineyoMedical (Shanghai Xuan Yu Medical Device Co., Ltd.) announced the completion of a nearly RMB 100 million Series A+ financing round. This round was led by Guangzhou Jinkong Fund, with participation from multiple investment institutions including Zhuo Pu Capital, Jin Xin Capital, and Zhangjiagang Industrial Capital. Existing shareholder Xingzheng Capital continued its support. The funds from this round will primarily be used for the construction of the company’s commercialization team, acceleration of production base operations, and the development of the product pipeline, aiming to create a differentiated portfolio of cardiac electrophysiology and peripheral vascular intervention products.
03
China-Made Innovative Medical Device, Transcatheter Aortic Valve System, Approved
Recently, the National Medical Products Administration approved the registration application of Shanghai NewMed Medical Technology Co., Ltd. for its innovative product, the "Transcatheter Aortic Valve System." The product consists of a transcatheter aortic valve, a transcatheter aortic valve delivery system (including a delivery device and valve loader), an aortic valve balloon dilation catheter, a crimping device, and a balloon inflation device. The Transcatheter Aortic Valve System is the first domestically produced balloon-expandable transcatheter aortic valve product in China. It is suitable for patients aged 70 or older who, after evaluation by a cardiac team using a scoring system, are diagnosed with symptomatic, calcified, severe degenerative native aortic valve stenosis and are not suitable candidates for conventional surgical valve replacement.
04
World's First msRDN Mapping Device Approved by NMPA
Recently, SyMap's self-developed world's first renal nerve mapping/selective ablation (msRDN) system has successfully obtained NMPA approval for marketing. This achievement marks the rise of innovative technology in the RDN field produced in China, indicating technological breakthroughs and market potential in this area in China. SyMap’s innovative product will provide a new option for the treatment of hypertension. SyMap’s renal nerve mapping/selective ablation (msRDN) system passed through the "Special Review Procedure for Innovative Medical Devices," becoming the first msRDN device approved by the National Medical Products Administration (NMPA) for marketing. It is also the world’s first radiofrequency ablation product capable of mapping renal nerves, which can provide precise ablation locations for renal denervation procedures, as well as effective feedback during and after the procedure to evaluate the immediate effects of renal denervation, meeting clinical needs for renal nerve ablation.
05
China-Made Four-Arm Laparoscopic Surgical Robot Breaks Below 10 Million Yuan
Recently, the Jiangxi Government Procurement Website announced the winning bid results for Jiujiang First People's Hospital’s surgical robot: the domestically produced Jingfeng four-arm laparoscopic surgical robot MP1000 and the Tianzhihang orthopedic robot were awarded the contract at a bundled price of 16.145 million yuan. The lowest winning bid price for the Tianzhihang orthopedic robot was approximately 7 million yuan, leading to the inference that the winning bid price for the Jingfeng surgical robot MP1000 could be below 10 million yuan; thus, this winning bid may mark the first time that a domestically produced four-arm laparoscopic surgical robot has been priced below 10 million yuan. By 2023, 28 surgical robot products had obtained registration certificates, with the overall market experiencing explosive growth. Although the Da Vinci surgical robot held an absolute advantage in 2023, multiple domestic competitors also gained approval in 2023 or 2024 and are expected to enter the market in 2024.
06
Heavyweight Launch! The All-New Chinese-Made Multi-Port Surgical Robot Jingfeng MP2000 Has Arrived
On August 10, the "2024 Chinese Medical Doctor Association Urological Surgeons Branch (CUDA) Annual Conference," hosted by the Chinese Medical Doctor Association and the Urological Surgeons Branch of the Chinese Medical Doctor Association, grandly opened in Xi'an. At this grand event, the all-new generation of Jingfeng® Multi-Port Endoscopic Surgical Robot MP2000 made its heavyweight debut — with seven major advancements, it reached new heights in overall performance, dazzling the entire audience.
07
Neusoft Medical's World's First Quantum-Level Fully Digital "NeuEra Series PET/CT" Approved for Marketing
On August 14, 2024, NeuEra Series PET/CT, the world's first fully digital PET/CT with a time resolution of 180ps developed independently by Neusoft Medical, officially received medical device registration approval from the National Medical Products Administration (NMPA). Featuring proprietary core technologies and optimized clinical solutions, the fully digital NeuEra Series PET/CT represents the latest generation of molecular imaging product innovation from Neusoft Medical. Equipped with five specialized research platforms—oncology, cardiology, neurology, pulmonology, and dynamics—it offers more comprehensive solutions for clinical research.
08
GenesisX: Latest Generation Vascular Intervention Robot Receives CE Approval | FDA Registration Application Submitted
Stereotaxis Announces CE Approval for Its Latest Generation Vascular Intervention Robot—GenesisX and Submits FDA Registration ApplicationFounded in 1990 and headquartered in St. Louis, Missouri, USA, Stereotaxis is a medical device manufacturer and the global leader in robotic technologies for electrophysiology innovation. The company focuses on providing robotic systems and integrated solutions for interventional catheterization labs, applicable to procedures such as electrophysiology interventions. These systems assist physicians in delivering higher precision and safer surgical treatments for patients while improving operational efficiency in catheter labs and enhancing the integration of procedural information.
09
Siemens Healthineers' New AI-Powered Cardiovascular Ultrasound System Receives FDA Approval
Recently, Siemens Healthineers has received approval from the U.S. Food and Drug Administration (FDA) for its Acuson Origin, a new cardiovascular ultrasound system with advanced artificial intelligence (AI) capabilities. The ACUSON Origin is an all-in-one workhorse product that can be used for diagnosis, structural heart, EP, and pediatrics – addressing the entire patient care continuum.
10
Kehua Bioengineering (002022.SZ): "Fully Automatic Nucleic Acid Extraction and Fluorescence PCR Analysis System" Obtains Medical Device Registration Certificate
Kehua Bio-engineering (002022.SZ) announced that its controlling subsidiary, Xi'an Tianlong Science and Technology Co., Ltd., has received a medical device registration certificate issued by the National Medical Products Administration, for the product: "Automatic Nucleic Acid Extraction and Fluorescence PCR Analysis System." Shanghai Kehua Bio-engineering Co., Ltd. (referred to as Kehua Bio-engineering) is an in-vitro diagnostic company that integrates research and development, production, and sales, with rich production experience and a complete range of medical diagnostic products. Kehua Bio-engineering takes R&D innovation as its core driving force, building two major R&D technology platforms for clinical in-vitro diagnostic reagents and fully automatic testing and analysis instruments, achieving "serial" and "integrated" diagnostic reagents and instruments.
11
Lepu Medical "PeakSheath™ Single-Use Vascular Sheath" Obtains Medical Device Registration Certificate
News on August 13, 2024: Approved by the National Medical Products Administration (NMPA), the "PeakSheath™ Single-Use Vascular Sheath" for peripheral vessels, developed by Lepu (Beijing) Medical Devices Co., Ltd., has successfully obtained the medical device registration certificate of the People's Republic of China, with the registration number: JingXieZhuZhun 20242030402. The single-use vascular sheath is used for percutaneous puncture insertion into the vascular system to introduce guidewires, catheters, and other medical devices. Renke Biotechnology is a high-tech biotech company led by Tsinghua University and Peking University Cancer Hospital, possessing cutting-edge global genomics and tumor gene detection technologies. Established in 2021, the company is a developer of pan-cancer chromatin quality testing technology, aiming to address industry pain points and build a blood health big data platform. Since its establishment, Renke Biotechnology has adhered to the concepts of technological innovation and scientific exploration, promoting the innovative research and clinical application transformation of frontier technologies such as liquid biopsy and multi-cancer early detection, and is committed to advancing the development of China's precision oncology diagnosis and treatment industry.
12
China's National Medical Products Administration Center for Device Review Releases 12 Guiding Principles for the Registration Review of Medical Device Products
On August 12, 2024, the Center for Medical Device Evaluation of the National Medical Products Administration released 12 registration review guidelines for medical device products, namely: "Guidelines for the Registration Review of Hydrogel Dressings," "Guidelines for the Registration Review of Dialysate Filters," "Technical Review Guidelines for Single-Use Side-Hole Blunt Needles," "Guidelines for the Registration Review of Single-Use Intravenous Catheters," "Guidelines for the Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials, Part III: Biocompatibility Toxicological Evaluation," "Guidelines for the Registration Review of α-Cyanoacrylate Medical Adhesives (2024 Revised Edition)," "Guidelines for the Registration Review of Absorbable Anti-Adhesion Products for Abdominal and Pelvic Surgery (2024 Revised Edition)," "Guidelines for the Registration Review of Absorbable Surgical Sutures (2024 Revised Edition)," "Guidelines for the Registration Review of Absorbable Hemostatic Products (2024 Revised Edition)," "Guidelines for the Registration Review of Single-Use Membrane Oxygenators (for CPB) (2024 Revised Edition)," "Guidelines for the Registration Review of Single-Use Cerebrospinal Fluid Shunts (2024 Revised Edition)," and "Guidelines for the Registration Review of Single-Use Hemodialysis Tubing Sets (2024 Revised Edition)."
13
Xiamen Issues Regulations for the Management of Automated Medical Device Vending Machines
Recently, Xiamen City took the lead in issuing the "Regulations on the Management of Automatic Vending Machines for Medical Devices in Xiamen City" across the province. The regulations clarify the filing process for medical device operating enterprises setting up automatic vending machines and impose requirements on the business entities, scope of operations, basic principles, and quality management systems of these vending machines. After the implementation of the Regulations, qualified medical device operating enterprises can set up automatic vending machines in places such as hospitals, communities, and shopping malls to sell Class I and II medical devices that consumers can use individually, meeting the 24-hour purchasing needs of consumers and the urgent clinical demands of hospital patients, further improving the accessibility of medical devices. Meanwhile, enterprise operation models will become more flexible and diverse, allowing companies to deploy multiple automatic vending machines within the city, breaking the traditional model of one store per business location.
14
Public Announcement of the Winning Units for the Innovative Task of Artificial Intelligence Medical Devices
Recently, according to the Notice on Organizing and Carrying Out the Bidding Work for Innovative Tasks of Artificial Intelligence Medical Devices (Letter [2021] No. 247 from the Ministry of Industry and Information Technology), the Department of Science and Technology of the Ministry of Industry and Information Technology and the Medical Device Registration Department of the National Medical Products Administration conducted an evaluation of the results of the bidding projects. A total of 104 outstanding units were initially selected. To further solicit opinions from all sectors of society, the proposed list of winning units for innovative tasks of artificial intelligence medical devices is now being announced for public review. Public announcement period: August 9 to 15, 2024.
15
Shanghai Launches the Collection Work for the Biomedical "New and Excellent Medical Devices" Product Catalog
Recently, in order to promote the innovative development of the biopharmaceutical industry, and in accordance with the spirit of documents such as "Several Opinions of the General Office of the Shanghai Municipal People's Government on Supporting the Full-chain Innovative Development of the Biopharmaceutical Industry," the Shanghai Science and Technology Commission organized and carried outCall for Entries: 2024 Shanghai Biomedical "New and Excellent Pharmaceutical and Medical Device" Product Directory. Products applying to be included in the directory must have been first approved for marketing after January 1, 2019, and must be produced within Shanghai. They should possess strong innovation, high clinical value, good safety, reliable quality, and clear intellectual property rights, as well as demonstrate market potential and industry leadership. Among these, "innovative products" refer to medical devices that have been approved for marketing through the special review process for innovative medical devices by national or municipal drug regulatory authorities. "Famous and excellent products" refer to medical devices with relatively strong innovation in working principles or mechanisms of action.
16
NMPA: Medical Device Licenses and Registrations Information Available for Each Province in China
Recently, in order to further meet the needs of enterprises and the public to query medical device regulatory information, and to strengthen social supervision and social co-governance, the National Medical Products Administration (NMPA) has compiled the information of all provinces (autonomous regions, municipalities) within the validity period (as of...(July 31, 2024) The registration and filing of medical device products, the licensing and filing of medical device manufacturing enterprises, the licensing and filing of medical device trading enterprises, the filing of online sales of medical devices, and the filing information of third-party platforms for medical device online trading services are published on a monthly basis. Specific data can be queried by clicking on the medical device module on the data query page of the National Medical Products Administration.
17
CMDE Seeks Public Comments on 2 Industry Standards Including "Real-World Data Terminology and Definitions for Medical Devices"
Recently, according to the 2024 work plan for standard formulation by the China Medical Device Clinical Evaluation Standardization Technical Committee, the committee has completed the draft for public comment and related materials of two industry standards: "Medical Device Real-World Data - Terminology and Definitions" and "Requirements for Biological Sample Management in Clinical Trials of In Vitro Diagnostic Reagents." It is recommended that these two standards be implemented 12 months after their release. Public opinions are now being solicited. Relevant organizations are requested to arrange personnel to provide comments or suggestions on the draft for public comment, the preparation instructions (Attachments 1-2), and the proposed implementation date, and submit feedback via email before October 8, 2024.
Note: The information in this article is compiled based on online news.
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