Alcon Invests ¥427 Million in U.S. IOL Manufacturing Expansion Amid NMPA Approvals of Multiple Innovative Medical Devices

1. NMPA Approves Multiple Innovative Medical Device Products for Market Launch

Recently, the National Medical Products Administration (NMPA) approved the registration applications for several innovative medical device products, including a cross-linked polyisobutylene aspheric intraocular lens and a cardiac cryoablation system. Among these, the cross-linked polyisobutylene aspheric intraocular lens developed by Eyedeal Medical Technology Company Limited is a single-piece posterior chamber intraocular lens that is foldable with dual C-loop haptics. Both the lens body and haptics are made of hydrophobic cross-linked polyisobutylene material with an added UV absorber. The optical design of the intraocular lens is monofocal and aspheric. This product is intended for vision correction in adult aphakic eyes following cataract removal surgery. The cardiac cryoablation system developed by Shenyang Pengyue Technology Co., Ltd. consists of a main unit, an argon gas delivery line, a helium gas delivery line, and an optional disposable sterile thermometer. The disposable sterile cryoablation probe comprises a probe tip, a handle, connecting tubes, and a thermocouple. These two products are used together primarily for treating persistent atrial fibrillation in adult patients with heart disease. (China Securities Network)

2. Anhui Issues Risk Consultation Work Guidelines for Medical Device Manufacturers

Recently, in order to promote the establishment of a scientific and efficient risk consultation mechanism among high-risk medical device manufacturers, the Anhui Provincial Drug Administration issued the "Guidelines for Risk Consultation Work of Medical Device Manufacturers in Anhui Province (Trial)" based on the preliminary organization of trial operations by 10 high-risk medical device manufacturers within the province. The aim is to further strengthen the primary responsibility of medical device manufacturers for product quality and safety, enhance risk control throughout the product lifecycle, and ensure product quality and safety. The Guidelines provide clear instructions on aspects such as the scope, principles, organization, process, frequency, record documentation management, and training dissemination of risk consultations for medical device manufacturers, offering clear guidance for enterprise risk consultation work. (Xinhua News Agency)

3. Medtronic's Best-Selling Products Launch in China

Recently, at the 4th Global Digital Trade Expo, Medtronic showcased its newly approved fourth-generation Pipeline™ Vantage with Shield Technology™ surface-modified flow-diverting stent. The launch of Pipeline™ Vantage not only marks a new phase in the treatment of cerebral aneurysms that is less invasive and safer, but also provides Chinese patients with more diverse and higher-quality treatment options. Data shows that the Pipeline™ Embolization Device was acquired by Medtronic in its $43 billion purchase of Covidien in 2015. It is currently a popular product in the field of flow diversion and the most extensively researched flow-diverting stent globally. This therapy has been available in the Chinese market for ten years and has now been updated to its fourth generation. To date, more than 250,000 patients globally and over 40,000 patients in China have benefited from it. (Innovation Network of Medical Devices)

4. Minimally Invasive Medical Announces Strategic Restructuring of Cardiac Rhythm Management Business

Recently, MicroPort Medical announced that it has signed a merger agreement with CRM Cayman, MicroPort CardioFlow, and MicroPort CardioFlow CRM Limited to carry out a strategic reorganization of its cardiac rhythm management business. According to the merger agreement, MicroPort CardioFlow will issue new shares at an issue price of HK$1.35 per share to shareholders of CRM Cayman. The pre-transaction equity value of CRM Cayman is US$680 million, determined through fair negotiations between both parties and based on the assessment by an independent professional valuer. After the merger, CRM Cayman and its subsidiaries will become indirect subsidiaries of MicroPort CardioFlow. This transaction is considered in line with the strategic development of MicroPort CardioFlow, helping to build a global cardiology product platform and achieve product diversification and synergies. (Hexun.com)

5. Endoscopic Robot Completes Remote Pyeloplasty in Pediatric Patients

Recently, SS Innovations announced the successful completion of a pediatric pyeloplasty remote surgery using the company's self-developed SSi Mantra surgical robotic system. To date, the SSi Mantra surgical robotic system has successfully completed over 50 remote surgeries across a distance of 4,000 miles, covering the following fields: pediatric surgery, cardiac surgery, urology, gynecology, oncology, and general surgery. SS Innovations believes it is addressing the unmet robotic surgery needs of the continuously growing pediatric surgery market, which aligns closely with its mission to provide world-class medical services to underserved areas. The plan is to further expand the SSi Mantra’s technical capabilities in pediatric robotic surgery by developing smaller instruments. (Medical Device News)

6. Alcon Invests 427 Million in Factory Expansion

Recently, Alcon, headquartered in Geneva, Switzerland, announced another expansion — the completion of its factory expansion project in Razeach, West Virginia, with a total investment of 427 million RMB (60 million USD). This makes the Razeach facility, which has decades of history in vision product manufacturing, the core production site for Alcon's intraocular lenses (IOL) in the United States. More notably, Alcon is planning to relocate two European production lines to its existing campus in Fort Worth, USA. If these two production lines are successfully relocated, Alcon will invest an additional 186 million USD (approximately 1.322 billion RMB) in the local Fort Worth area and create 241 full-time jobs, with an average annual salary of 75,000 USD for employees. (Medical Device Innovation Network)

7. What is the medical device public service platform?

The Medical Device Public Service Platform is a key initiative co-developed by the Orthomed Group in collaboration with local governments, industrial parks, medical institutions, and research universities. It focuses on incubating, transforming, and investing in cutting-edge and innovative global medical device projects. By establishing research and transfer mechanisms that align with international standards, it operates under an open and shared model. This attracts top-tier researchers, doctors, and innovators from around the world to join the platform. It provides comprehensive industry technical services covering R&D transformation, incubation, and investment, nurturing innovative medical device achievements with significant innovation and application value. The platform strongly supports the development of the medical device industry and technological innovation. (Compiled by Orthomed)

8. Wuhan Amulet Life Science Co., Ltd. Submits Listing Application to HKEX

Recently, Wuhan Amulet Life Science Co., Ltd. submitted an application for listing to the Hong Kong Stock Exchange, with joint sponsors being CCB International and Bank of Communications International. Founded in January 2015, Amulet is an early cancer detection company strategically focused on cancers with high incidence and mortality rates. It was the first to develop early cancer detection technology based on methylation. As of the latest practicable date, Amulet has two core products: Aixinggan for liver cancer and Aiguangle for urothelial cancer. Aixinggan is a liver cancer detection reagent based on methylation technology using real-time quantitative polymerase chain reaction ("qPCR") technology, with a sensitivity of 92.33% and specificity of 93.35% in detecting liver cancer through blood samples, and its sensitivity for Stage I patients is as high as 84.43%. Amulet's other core product, Aiguangle, only requires a 1-milliliter urine sample to achieve non-invasive detection of urothelial cancer, significantly improving efficiency and convenience compared to traditional methods. (Gelonghui)

1. The Sixth Batch of Standardized Governance on Medical Service Prices by the Guangdong Provincial Medical Insurance Bureau

Recently, the Guangdong Provincial Medical Insurance Bureau announced the Notice on the Standardization of Medical Service Prices (Sixth Batch). According to the governance objectives, the prices for continuous dynamic blood glucose monitoring projects in our province will be adjusted (see attachment for details). Local areas will announce specific prices within the range not exceeding the provincial maximum price limit. Prices cannot be increased, but reductions are allowed without restriction. Newly piloted items include *Mycobacterium tuberculosis rpoB gene and mutation detection (real-time fluorescent PCR method)*, *Mycobacterium tuberculosis drug-resistance gene detection*, and *Mycobacterium identification - fluorescent PCR melting curve method*. Medical insurance departments in various regions will guide medical institutions to proactively reduce registered prices to meet or fall below the target level. Prices among medical institutions of different levels within the same region should remain relatively coordinated. (Guangdong Provincial Medical Insurance Bureau)

2. All-China Federation of Trade Unions and National Healthcare Security Administration Sign Data Sharing Cooperation Agreement

Recently, the All-China Federation of Trade Unions and the National Healthcare Security Administration signed the "Data Sharing Cooperation Agreement" in Beijing. This marks a substantive step in promoting the organic integration of employee mutual aid insurance and the national healthcare security system, promising more convenient and precise security services for the vast number of workers. According to the agreement, both parties will follow the principles of "safety compliance, complementary advantages, and collaborative efficiency" to establish a data-sharing mechanism that breaks down information barriers between employee mutual aid insurance and basic medical insurance. This will provide strong data support for facilitating the settlement of employees' medical expenses, accurately verifying benefits, and promptly assisting employees in need. Through the "Workers' Home" app, employees can enjoy "quick and precise claims" for mutual aid insurance, providing them with convenient services such as "one-click application and fast subsidies." (Beijing Youth Daily)

3. Fuwai Hospital West Campus to Be Activated

Recently, the 2025 China Heart Congress Innovation and Transformation Forum and Jingxi Innovative Pharmaceutical and Device Industry Development Conference were held in Beijing. Hu Shengshou, academician of the Chinese Academy of Engineering, director of the National Cardiovascular Disease Center, and president of Fuwai Hospital, Chinese Academy of Medical Sciences, stated at the conference that the West Campus of Fuwai Hospital will soon be commissioned in the Jingxi Mentougou District. This hospital is a data-driven modern innovative translational research hospital and will become an internationally leading cardiovascular innovation and transformation base in the future. The hospital will also deepen its cooperation with Mentougou District to jointly build the Zhongguancun Mentougou Cardiovascular Pharmaceutical and Device Industrial Park and create "China Heart Valley." The National Key Laboratory of Cardiovascular Diseases, Suzhou CH Biomedical Co., Ltd., and Beijing Fuwai Heart Valley Technology Co., Ltd. have officially settled in "China Heart Valley," simultaneously launching the China Heart Valley Innovation Workshop for routine incubation of innovative pharmaceutical and device projects in the cardiovascular field. (China News Service)

4. Tencent Invests in IVD Company

Recently, Shanghai Minwei Biotechnology Co., Ltd. underwent industrial and commercial changes, adding Guangxi Tencent Venture Investment Co., Ltd. as a shareholder, while the registered capital increased to approximately 16.16 million yuan. According to Qichacha (a business information platform), Shanghai Minwei Biotechnology Co., Ltd. engages in technology development, technical consultation, technology transfer, and technical services within the fields of biotechnology and medical technology (excluding the development and application of human stem cells, gene diagnosis, and treatment technologies). It also develops, produces, and sells instruments and equipment, plastic products, laboratory equipment and materials, and develops and sells computer software. (Except for projects that require legal approval, it operates independently under the business license.) Licensed projects: technology import and export; goods import and export. (For projects subject to legal approval, activities can only be carried out after approval by relevant departments, with specific business projects based on approval documents or licenses from relevant authorities.) (In Vitro Diagnostics Network)

5. Artificial Cochlear Surgery Robot iotaSOFT Completes 1000 Clinical Surgeries

Recently, iotaMotion announced that its cochlear implant surgery robot --- iotaSOFT has completed over 1,000 clinical surgeries, reaching a new milestone. iotaSOFT is an open-style cochlear implant surgery robot. It aims to reduce surgical variability by achieving electrode array implantation with robotic consistency and control beyond human capabilities. The core advantage of iotaSOFT lies in its robot-assisted control, which slows down the insertion speed of the electrode array to a range beyond human ability (0.1 mm/sec to 1.0 mm/sec). A slow and steady insertion speed reduces insertion force, and lowering the speed and force can minimize intracochlear trauma. iotaSOFT reduces maximum insertion force by 51% and decreases insertion force variability by 78%. Clinical studies have also confirmed that the precision and speed of iotaSOFT result in less trauma. (MedTF)

6. Flexible Endoscopic Surgical Robot Approved by FDA

Recently, a Key Breakthrough in Endoscopic Surgical Robot Technology. Innovative medical device company EndoRobotics announced that its self-developed gastrointestinal endoscopic surgical robot system, ROBOPERA, has received approval from the U.S. Food and Drug Administration (FDA) for market launch. The system covers three core product categories: FDF (endoscopic grasping and closure device), FDS (endoscopic tissue stapling system), and NAY (robot-assisted endoscopic accessories). While maintaining high compatibility with traditional gastroenterological endoscopy systems, it provides robotic assistance for therapeutic endoscopic procedures, marking a significant step toward the practical application of flexible endoscopic surgical robot technology. EndoRobotics is an innovative medical device company specializing in flexible gastrointestinal endoscopic surgical robots, committed to upgrading traditional endoscopy platforms into surgical solutions with therapeutic capabilities through intelligent, modular assisted surgery systems. (MedRobot)

7. R&D Design Services Accelerate the Clinical Transformation 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. Ossdora 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 scientific 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 and 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, Ossdora has had more than 200 projects enter the review stage, over 100 projects under development, with a 100% success rate in transformation. (Compiled by Ossdora)

8. Unnamed Times Completes Tens of Millions of Yuan in B+ Round Financing

Recently, Weiming Shiguang, an innovative enterprise in bioactive raw materials, has successfully completed a B+ round of financing worth tens of millions of RMB. This round of financing was jointly invested by Huatai Genscript and Haibang Investment. This follows nearly 100 million RMB in investment from L'Oréal and Nice Group in May this year, marking another strong support from industrial capital. The funds from this financing will focus on deepening the construction of AI technology platforms, expanding the diverse application scenarios of biomaterials, and accelerating the globalization of business layout, injecting strong momentum into the continuous innovation and development in the field of bioactive raw materials. Weiming Shiguang is a technology company specializing in the research and production of bio-based innovative materials. Weiming Shiguang has built an "AI + synthetic bio" material innovation and production platform. Based on product requirements across various scenarios from daily care to medical applications, it uses AI to design materials and designs specific biological cell factories to produce raw materials, providing downstream customers and end markets with green, safe, and effective raw materials and products. (VcBeat)