Medical Device Weekly Roundup [Nov 4–10]: Funding, Approvals, and IPO Filings Highlight Sector Momentum
ZD Medical
Developer, Manufacturer, and Supplier of Advanced Ophthalmic Medical Devices
ROBO Medical
Medical Robot Developer
AMIT
Integrated Intelligent Healthcare Solutions Provider
01
ZD Medical Completes Nearly 100 Million YuanSeries C Financing Accelerates R&D and Innovation of Ophthalmic Medical Devices
On November 5, ZD Medical completed a nearly 100-million-yuan C-round financing, led by Taipu Life Science, with participation from Hanking, Huiding, Mifang, and Yangyun. The aim is to accelerate the research, development, and innovation of ophthalmic medical equipment and enhance diagnostic capabilities for fundus diseases. ZhiDing Medical Technology (Hang Zhou) Co., Ltd. was established on January 19, 2015, focusing on the R&D, production, and sales of high-end ophthalmic medical devices. As a high-tech enterprise, ZD Medical has an optical R&D center in the United States and gathers numerous scientific elites from home and abroad. The company's main products include Optical Coherence Tomography (OCT/OCTA), dry eye detectors, dry eye treatment devices, and other high-end ophthalmic equipment, all of which have independent intellectual property rights.
02
ROBO Medical AwardedSeries A+ Financing, Gastrointestinal Endoscopy Surgical Robot Approval Imminent
On November 6, ROBO Medical secured an A+ round of financing from Hangzhou Guoshun Jianheng Investment. The funds will be used to promote the market expansion of the company’s EndoFaster endoscopic surgical robot and support the research, development, and market entry of multiple innovative medical products. ROBO Medical, established on May 11, 2015, focuses on the research and industrialization of endoscopic surgical robots. The company's main product is the EndoFaster Endoscopic Surgical Robot System, one of the globally leading natural-orifice surgical robots, known for its high control precision, flexibility, and low complication rates. EndoFaster provides auxiliary operation for doctors in confined spaces by attaching a 2.5mm-diameter flexible robotic arm to the outer side of an endoscope.
03
Hangzhou Milli Technology Co., Ltd. CompletedPre-A Round Financing to Advance the Development of Products in the Pipeline
On November 5, Hangzhou Milli Technology Co., Ltd. completed its Pre-A round of financing, led by DeShi Capital and followed by Juschuang Capital. The funds will mainly be used for the construction of a production base for agarose-based beads at the ten-thousand-liter scale, accelerating the mass production and commercial promotion of the company's products. Established in 2022, Hangzhou Milli Technology Co., Ltd. focuses on the development of microfluidic production chips and has expanded this technology into a universal production platform for microsphere materials in the life sciences field. The company has achieved a highly digitized production model, compatible with a variety of raw materials including agarose, inorganic materials, and plastic polymers, enabling the rapid scaled production of microspheres with different particle sizes and functionalities. Its main products include microfluidic chips, microfluidic systems, and related supporting equipment and services, widely used in biopharmaceutical purification processes, drug encapsulation and delivery, Car-T cell screening, in vitro diagnostics (IVD), and medical aesthetic materials.
04
AMIT Completes Tens of Millions of Yuan in FinancingSeries A Financing to Accelerate the Launch of Real-Time Ultrasound-Guided Puncture Navigation Robots
On November 1, AMIT completed its multi-million-yuan Series A financing round, exclusively invested by Qianhai Ark Great Health Fund. Beijing AMIT Medical Science and Technology Co., Ltd., established in 2021, specializes in providing intelligent medical robotic systems, devices, and comprehensive smart healthcare solutions. The company focuses on robotic system solutions for minimally invasive cancer therapies, relying on the Future Robotics Research Center at Waseda University, and has accumulated hundreds of technologies in medical imaging, navigation, artificial intelligence, robotics, advanced manufacturing, and medical materials. Its main products include intelligent medical devices such as ultrasound-guided biopsy navigation systems and ultrasound-guided biopsy brackets, which have been validated through animal experiments and are currently undergoing pre-clinical trials.
05
Fenghe Medical Completes IPO Coaching Filing Work
On November 4, the official website of the China Securities Regulatory Commission (CSRC) announced important information: Jiangsu Fenghe Medical Devices Co., Ltd. ("Fenghe Medical" for short) has officially completed the filing of its IPO tutoring. This tutoring is conducted by CICC as the tutoring institution, while the Jiangsu CSRC Bureau, as the regulatory branch, will participate in and supervise the entire tutoring process. Jiangsu Fenghe Medical Devices Co., Ltd., established in October 2011, is an innovative enterprise that focuses on the research, development, production, and sales of minimally invasive surgical instruments and consumables, and is a leading company in China. Since its establishment, the company has been committed to independent research and technological innovation, developing high-performance minimally invasive surgical instruments to meet the growing and evolving clinical needs of minimally invasive surgery. After more than a decade of technical accumulation and iteration, the company has built a comprehensive product portfolio and advanced product layout, including endoscopic staplers, electric endoscopic staplers, manual endoscopic staplers, open staplers, and other minimally invasive surgical instruments such as trocars, ligation clips, and clip appliers.
06
Cerebral Medical "Intracranial Aneurysm Embolization Assist Stent" Approved for Marketing, Used for Assisted Embolization and Blood Flow Reconstruction
On November 4, Cerebral Medical's intracranial aneurysm embolization assist stent was approved for marketing. The product consists of a stent, delivery wire, and introducer sheath, used to assist in embolization and blood flow reconstruction. The product comprises three parts: the stent, delivery wire, and introducer sheath. The stent is made from nickel-titanium alloy tubing via laser cutting, with platinum-iridium marker points at both ends and in the middle section of some models, facilitating precise clinical judgment of stent deployment and wall apposition. Under standard interventional surgical conditions, the position of the intracranial aneurysm is determined through angiography, and the device is used for endovascular-assisted embolization and blood flow reconstruction in patients with intracranial aneurysms.
07
Yabone Xi "Medical Knee Joint Prosthesis System" Approved for Marketing, Intended for Primary Knee Replacement Surgery
On November 4, Yaboneixi Medical's knee joint prosthesis system was approved for marketing. The product is suitable for primary knee replacement surgery and features an additively manufactured trabecular porous structure. The system consists of femoral components, tibial components, and patellar components, and is intended for primary knee replacement in skeletally mature patients. Both the femoral condyle and tibial tray incorporate trabecular porous structures manufactured using additive processes, providing a high friction coefficient and excellent bone integration properties.
08
Beckman Medical "Sperm Quality Analyzer (BKA210)" Obtains Medical Device Registration Certificate
On November 1, BGI Medical's sperm quality analyzer (BKA210) obtained the medical device registration certificate issued by the Jiangsu Drug Administration. This equipment can quickly and accurately analyze the quality of unstained live sperm.
09
Weigao Interventional Second-Generation Vena Cava Filter Launch
Recently, the Caval Vein Filter developed by Shandong Weixin Medical Device Co., Ltd. (referred to as "Weixin Medical"), a subsidiary of Weigao Group, has officially obtained the "Medical Device Registration Certificate of the People's Republic of China" issued by the National Medical Products Administration. This Caval Vein Filter is the second-generation system independently developed and produced by Weixin Medical. The product includes a filter, a delivery device, and a retrieval device. The filter is made of superelastic shape-memory alloy; the delivery device consists of a delivery sheath, a delivery sheath core, a delivery cable, and a guiding sheath; the retrieval device consists of a retrieval sheath and a retrieval sheath core. This product is used to prevent pulmonary embolism (PE) caused by the detachment of thrombi in the inferior vena cava system.
10
Changmu Valley Medical Technology Co., Ltd. independently developedNAVIplasty®Intelligent Hip Surgery Robot Officially Approved for Marketing
Recently, the NAVIplasty® Intelligent Hip Surgery Robot, independently developed by Beijing Changmu Valley Medical Technology Co., Ltd. (Changmu Valley®), has officially been approved for marketing by the National Medical Products Administration (NMPA) (Registration Certificate No.: Guo Xi Zhu Zhun 20243011934), becoming a Class III medical device with AI-assisted orthopedic treatment capabilities. Compared with traditional hip replacement surgery, the NAVIplasty® Intelligent Hip Surgery Robot offers significant advantages, addressing the issues of “inaccuracy and instability” faced by doctors, assisting them in precisely completing prosthesis implantation with accuracy far surpassing traditional replacement procedures, reducing risks caused by "imprecision." Close collaboration between medical and engineering teams, along with rigorous scientific research and clinical verification, has fully validated its technical reliability and safety.
11
Johnson & JohnsonPFA Ablation Catheter Receives FDA Approval for Market Launch
Recently, Johnson & Johnson announced that its PFA ablation catheter—VARIPULSE—has received FDA approval for market release and can be used to treat drug-refractory paroxysmal atrial fibrillation. In this new era of PFA, although Johnson & Johnson is slightly behind Medtronic and Boston Scientific, with its strong technical capabilities and deep expertise in the electrophysiology field, it is believed that Johnson & Johnson can catch up quickly and make up for the one-year lag. With the launch of VARIPULSE, the electrophysiology field has officially entered a "three-way battle" era, where Medtronic, Johnson & Johnson, and Boston Scientific will engage in non-bloody competition to treat 8 million patients. It remains to be seen who will stand out. Compared to Boston Scientific's products, Johnson & Johnson’s catheter (VARIPULSE) does not have significant advantages, but its core competitiveness lies in CARTO 3 and Johnson & Johnson’s ICE. When VARIPULSE + CARTO 3 + ICE are combined, they will create a remarkable chemical reaction.
12
CGN Proton Therapy Equipment Off the Production Line
Recently, the production base of domestic commercial multi-room proton therapy equipment, invested and built by China General Nuclear Power Technology Development Co., Ltd., has witnessed the rollout of its equipment. It is now officially ready for delivery to Chengdu Medical Investment West China International Cancer Treatment Center Hospital for installation and debugging. The production base initially has an annual supply capacity of 3 to 4 sets of proton therapy systems. After this equipment delivery, CGN Technological Development will continue to fulfill customer order demands and provide equipment debugging, operation, maintenance, and other services to multiple proton therapy centers across China, including Chengdu Medical Investment West China International Cancer Treatment Center Hospital. The CGN proton therapy equipment is equipped with a domestically produced 360° rotating gantry, which can flexibly adjust angles to precisely target the tumor area without moving the treatment bed. This effectively reduces field junction issues and demonstrates significant advantages in treating tumors in areas such as the nasopharynx, head and neck, and abdominopelvic regions.
13
Berger Medical Acquires Raynova
Recently, Shanghai BioGerm Medical Technology Co., Ltd. and Shenzhen Renovo Science and Technology Industrial Co., Ltd. officially signed a strategic merger and acquisition cooperation agreement. According to the cooperation agreement, Renovo will become a wholly-owned subsidiary of BioGerm Medical and maintain independent operations. This collaboration aims to integrate the advantageous resources of both parties to carry out comprehensive strategic cooperation in various aspects such as sales in China and internationally, product development, and scientific research projects, jointly promoting innovation and development in the medical industry. Shenzhen Renovo Science and Technology Industrial Co., Ltd., established in 2001, focuses on the research and development, production, sales, and service of in vitro diagnostic products and has been recognized as a "National High-tech Enterprise." It possesses a full range of well-structured diagnostic reagent product lines and is a company in China with dual technical platforms for glycated hemoglobin analyzers. Its customers are spread across 95 countries and regions worldwide, serving over 8,000 laboratories.
14
Ophthalmic Medical Device CompanyLumiThera Receives FDA Approval to Use Valeda for Treating Dry AMD Patients
Recently,LumiThera Inc.Announcing that the U.S. Food and Drug Administration has authorized salesValeda®Light delivery system for the treatment of patients with dry age-related macular degeneration (AMD).ValedaCorrected vision improved within 24 months.（BCVA）>5 letters or equivalent to a line on the eye chart. In key U.S.LIGHTSITE IIIIn the trial,ValedaThe treatment achieved its primary endpoint and was proven to be safe and effective in improving and maintaining vision.LumiTheraAccording to the de novo requirement with special controls, in the United StatesLIGHTSITE IIIClinical data submitted as part of the technical package toFDA。
15
Medical Device LeaderSell-off of Photovoltaic Cell Business for 634 Million
Recently, MediTech announced that the company will divest its photovoltaic cell business for a total transaction value of 6.34 billion yuan. In addition, MediTech recently established a joint venture with UBTECH Robotics, focusing on in-depth cooperation in AI intelligent services and medical care, jointly creating an innovative "medical + humanoid robot" model. This major asset sale is expected to help MediTech achieve capital recovery through restructuring, allowing it to focus on the development and upgrading of its core business. MediTech officially disclosed the "Major Asset Sale and Related Party Transaction Report," marking an important strategic adjustment for the company. According to the announcement, MediTech has decided to divest its photovoltaic cell business and fully commit to the research, development, and promotion of clinical medical management information system (CIS) application software and comprehensive clinical information solutions, further strengthening its presence in the medical informatization and healthcare services sectors.
16
Desomio Launches5G+8K Ultra-HD Endoscope
Recently, at the 90th China International Medical Equipment Fair (CMEF), Desomio showcased its star products — the 8K endoscope and 8K surgical microscope — demonstrating its outstanding capabilities and innovative achievements in the field of medical technology. Guangdong Desomio Medical Technology Co., Ltd. has seamlessly integrated 5G and 8K technologies to create two groundbreaking medical devices: the 8K endoscope and 8K surgical microscope. These two products utilize a full-chain "true 8K" technology solution, from front-end image capture, data transmission, and compression storage to back-end ultra-low latency image display, providing an unprecedented visual experience and operational convenience for medical surgeries.
17
Roche Diagnostics LaunchesLightCycler® PRO System Real-Time Fluorescence Quantitative PCR Instrument
On November 6, at the 7th China International Import Expo, Roche Diagnostics China announced the official launch of its new molecular testing platform, the LightCycler® PRO System Real-Time PCR Instrument (LightCycler® PRO), in China. The new LightCycler® PRO breaks through traditional technical limitations, equipped with 7 detection channels and 28 different combinations of detection modes, capable of completing 2,688 tests within an hour. With its excellent multiplex detection capabilities, it improves testing efficiency per unit time and increases testing diversity. This powerful feature highlights significant advantages in application scenarios such as multi-target detection of gastrointestinal bacteria. Roche Diagnostics conducted a study on gastrointestinal bacterial detection based on the LightCycler® PRO at multiple research centers in Germany. The results showed that the LightCycler® PRO achieved rapid and accurate differentiation of seven gastrointestinal bacterial targets in a single test well, including Salmonella, Aeromonas, Campylobacter, Plesiomonas, Shigella, and Yersinia, demonstrating excellent sensitivity and specificity.
18
Guidelines for the Special Review of Class II Innovative Medical Devices Released
On November 6, the Shanghai Instrument Review Center released the "Special Review Guidelines for Class II Innovative Medical Devices in the City" to standardize the review process and guide applicants in preparing their documentation.
19
Shandong Issues Regulations for Automated Medical Device Vending Machines
Recently, the Shandong Provincial Medical Products Administration issued the "Shandong Province Automatic Vending Machine Supervision and Management Measures (Trial)," which aims to standardize the retail operation of medical devices using automatic vending machines in response to new requirements in the development of the medical device industry. The Measures consist of...Article 14 covers the scope of application for automatic medical device vending machines, enterprise conditions, basic requirements, product requirements, change requirements, corporate responsibilities, and regulatory responsibilities. According to the Measures, medical devices sold via automatic vending machines should be those that consumers can use on their own, accompanied by specific safety instructions. The Measures further clarify that enterprises engaged in the retail operation of medical devices (excluding Class I and Class II medical devices exempt from operation filing) through automatic vending machines must be medical device retail or wholesale-retail enterprises that have obtained a Class II medical device operation filing number or a Class III medical device operation license.
20
Anhui Province Issues Centralized Procurement for In Vitro Diagnostics
Recently, the Anhui Provincial Medical Insurance Bureau issued a document titled "Notice on the Public Disclosure of Product Information for the 2024 Inter-Provincial Alliance's Centralized Volume-based Procurement of In Vitro Diagnostic Reagents," with the disclosure period ending on November 12. Participating manufacturers: A total of 137 manufacturers submitted products, without merging related enterprises. Products from 28 manufacturers exceeded 20 in quantity. Four manufacturers—Meikang Bio, Xiamen Wantai, Suzhou Lihé, and Changguang Huayi—possess complete registration certificates for all 25 volume-based procurement products. Meanwhile, firms such as Maik, Mindray, New Industries Biomedical, Yahelon, and Antu each hold 24 registration certificates. Project submissions: Among the 25 projects included in this centralized procurement, the two items with the highest number of participating manufacturers are Carcinoembryonic Antigen (CEA) and Thyroxine (T4), both with 93 manufacturers. The item with the fewest manufacturers is Complexed Prostate-Specific Antigen (CPSA), with only five participants: Meikang Bio, Siemens, Xiamen Wantai, Changguang Huayi, and Suzhou Lihé.
21
Zhejiang Provincial Drug Administration ReleasesAnnouncement on the Approval and Registration of Class II Medical Device Products in October
Recently, the Zhejiang Provincial Drug Administration announced that in October 2024, a total of 72 Class II medical device products were approved for registration, including 33 active devices, 23 non-active devices, and 16 in vitro diagnostic reagents. According to the jurisdiction of the registrants, among the 72 approved medical device products, 41 are from Hangzhou, 14 from Ningbo, 1 from Wenzhou, 1 from Huzhou, 3 from Jiaxing, 3 from Shaoxing, 2 from Jinhua, 2 from Quzhou, and 5 from Taizhou. Main products: disposable gastrointestinal nutrition infusion tubing, handheld color Doppler ultrasound system, endoscopic insufflator, negative pressure suction pump, disposable sputum collector, arthroscopic biting and cutting forceps, etc.
22
Fujian Provincial Drug Inspection Institution Conducts Cross-Evaluation of Medical Device Inspection Reports
Recently, the "Fifth Collaborative Area" of Fujian Provincial Drug Inspection Institutions organized a cross-peer review of medical device inspection reports at the Fujian Provincial Drug Examination and Verification Center. The inspection team randomly selected 10 completed medical device cases, covering four types of inspections: special inspections, production license inspections, quality management system registration checks, and document-based inspections. After reviewing the management system, inspection plans, inspection reports, and comprehensive evaluations, the inspection team unanimously agreed that the inspection reports from the Fujian Center met procedural requirements, with good report integrity, standardized problem descriptions, accurate conclusions, complete original records, and all process handling deadlines in compliance with requirements.
23
Heilongjiang ReleaseArgumentation Results of the 2024 Annual Procurement List for Imported Products
Recently, the Health Commission of Heilongjiang Province released the announcement of the argumentation results for the 2024 "Provincial Health Industry Government Procurement List of Imported Products (Draft)." According to the "Administrative Measures for Government Procurement of Imported Products," government procurement should prioritize domestic products. If imported products are indeed necessary, relevant regulations require review and argumentation, and purchases can only be made after approval by the financial department. This time, a total of 58 types of medical equipment passed expert argumentation, allowing provincial-level public hospitals directly under the Heilongjiang Provincial Party Committee to procure imported equipment without further argumentation. In accordance with the "Guiding Opinions of the General Office of the State Council on Promoting the Healthy Development of the Pharmaceutical Industry," if domestically produced drugs and medical devices can meet requirements, government procurement projects must, in principle, purchase domestically produced products. Aside from these 58 types of medical equipment, all other procurements must prioritize domestically produced equipment.
24
For Registration InspectionPublication of the National Standards and Reference Materials Catalog for IVD Reagents
Recently, the National Institutes for Food and Drug Control (NIFDC) released the "Notice on Publishing the 16th List of National Standards and Reference Materials for In Vitro Diagnostic Reagents for Registration Testing." The specific content is as follows: To implement the "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" (Order No. 48 of the State Administration for Market Regulation), with the joint efforts of all parties, 11 new varieties have been added based on the 15th list of national standards and reference materials for in vitro diagnostic reagents for registration testing. The following 243 varieties are now published: Insulin National Standard, Thyroid-Stimulating Hormone (TSH) Immunoassay National Standard, Luteinizing Hormone (LH) Immunoassay National Standard, Follicle-Stimulating Hormone (FSH) Immunoassay National Standard, Human Growth Hormone Immunoassay National Standard, Ferritin (Fer) National Standard, etc.
Note: The information in this article is compiled based on online news.
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