Weekly Medical Device News Roundup [Oct 21–27]: Innovations, Approvals, and Strategic Moves
MacroLux
Provider of Comprehensive Endoscopic Interventional Diagnosis and Treatment Solutions
Sigma Squares
Intelligent Vision Equipment and Software Developer, Provider of Comprehensive Enterprise-level Vision Solutions
MedSingLong
Medical Device Distributor
01
MacroLux Completes Over 100 Million YuanSeries B Financing to Accelerate the Global Expansion of Disposable Endoscopes
On October 23, MacroLux Medical Technology Co., Ltd. completed a Series B financing round exceeding RMB 100 million, led by Vivo Capital with continued investment from existing shareholders Legend Capital and Daotong Investment. The funds will be used to expand production capacity, accelerate new product development, and extend global market reach. Established in October 2020, MacroLux Medical Technology Co., Ltd. is an innovative medical technology enterprise specializing in disposable endoscopic interventional diagnosis and treatment. The company integrates research and development, production, sales, and services, with product planning covering multiple fields including urology, ICU, gynecology, emergency medicine, and anesthesia.
02
Sigma Squares Completes Hundreds of Millions in FinancingSeries B Financing: Empowering Medical Device and Pharmaceutical Production with Smart Manufacturing
On October 17, Sigma Squares (Beijing) Tech Co., Ltd. announced the completion of a multi-hundred million yuan Series B financing round. This round was led by Top Alliance Capital, with participation from Yuanhe Puhua, Yahu Investment, Yunhui Capital, Xiangcheng Jinkong Capital, Entropy One Capital, and Boxin Capital. Sigma Squares (Beijing) Tech Co., Ltd. began formal operations in early 2018, and its products include industry intelligent vision equipment, machine vision and industrial data platform software, as well as enterprise-level solutions providing comprehensive visual solutions for industrial manufacturing companies.
03
Be Bio Announces $82 Million Financing and Transition to Clinical-Stage Company
Recently, Be Biopharma, Inc. announced key milestones and a new round of funding as its program for hemophilia B, Be-101, enters the clinic, and its second development candidate for hypophosphatasia has also been unveiled. Both programs are built on Be Bio's robust and efficient BCM platform, which uses gene editing to engineer B cells to produce sustained levels of therapeutic proteins, resulting in durable, titratable, and potentially curative candidates that require no preconditioning and have the potential to become excellent genetic medicines. The company has completed an $82 million financing round and is supported by top venture capital firms and pharmaceutical companies, including ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol-Myers Squibb, and Takeda Ventures.
04
MedSingLong Completes Tens of Millions of Yuan in FinancingSeries A Financing
Recently, MedSingLong, an S2b enterprise focusing on the overseas expansion of medical devices, announced the completion of a multi-million yuan Series A financing round. This round was invested by Becoming Capital, and the funds will be used for corporate brand building, overseas market expansion, and the development of an AI data platform. Previously, MedSingLong completed a million-yuan angel round in 2017 and a multi-million yuan Pre-A round in 2019. MedSingLong is one of the first companies in China to engage in the overseas expansion of medical devices. As an S2b cross-border e-commerce company specializing in the export of medical devices, the company's products mainly consist of imaging and laboratory equipment and consumables. By selecting high-quality domestically produced medical devices and utilizing an efficient data-driven marketing system along with excellent after-sales service, the company aims to enhance the influence of Chinese medical devices in overseas markets.
05
MedLead Cardiac Rhythm Medical "PLATINIUM™ Series Implantable Cardioverter Defibrillator (ICD) Approved for Marketing in China, Paving the Way for Domestically Produced ICDs
On October 21, MedSingLong's PLATINIUM™ series of Implantable Cardioverter Defibrillators (ICD) officially received the medical device registration certificate issued by the National Medical Products Administration (NMPA), becoming the first domestically produced ICD approved for marketing in China and is about to be formally applied in clinical practice. The approved implantable cardioverter defibrillators include two model specifications: the dual-chamber PLATINIUM™ DR 1540 and the single-chamber PLATINIUM™ VR 1240.
06
TaoDao Medical "Kylin1800D Orthopedic Robot" Officially Approved for Providing Precise Surgical Assistance
On October 17, the Kylin1800D orthopedic robot-specific carbon fiber operating table developed by Tandao Medical was officially approved. By integrating robotic technology with medical imaging technology and enabling unified control through a central master control system, it provides doctors with high-quality three-dimensional X-ray images, while assisting in precise and stable surgical path positioning and guidance.
07
SugarJ Meditech's Self-Developed Gastric Bypass Stent System Receives Approval in the United StatesFDA "Breakthrough Medical Device Designation"
Recently, the gastric bypass scaffold system independently developed by Hangzhou Tangji Medical Technology Co., Ltd. has successfully obtained the FDA's "Breakthrough Device Designation." This not only fully demonstrates the breakthrough achievements and leading position of the gastric bypass scaffold system in the field of metabolic disease treatment, but also means that the gastric bypass scaffold system will receive priority review privileges before market entry, laying a solid foundation for its rapid entry into the U.S. medical market. The "Breakthrough Device Designation" is a special certification provided by the FDA for certain medical devices with potential breakthrough functions in medical treatment, diagnosis, or monitoring, aiming to accelerate the market entry process of urgently needed clinical products, ensuring patients can access safe treatment more quickly and effectively.
07
Gastric Bypass Stent System ObtainsFDA "Breakthrough Device Designation"
Recently, the gastric bypass stent system independently developed by Hangzhou Tangji Medical Technology Co., Ltd. successfully obtained the "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA). This is the first innovative product in China to receive the FDA's "Breakthrough Device Designation" for the minimally invasive treatment of nonalcoholic steatohepatitis (NASH) accompanied by fibrosis and obesity. This product has already received innovative approval from the National Medical Products Administration in January 2024, officially passing the registration application, and has achieved significant clinical outcomes in the two indications of weight loss and nonalcoholic fatty liver disease. This is the world’s first Class III innovative medical device certificate for intestinal intervention in treating obesity, filling the gap between pharmaceutical weight loss and surgical weight loss, and creating a new treatment pathway for the discipline of weight management.
08
Strategic Cooperation Shenzhen Fourth People's Hospital Signs Strategic Cooperation Agreement with Rayli Group to Promote Integration of Industry, Academia, and Research and Transformation of Innovative Achievements
On October 24, Shenzhen Fourth People's Hospital and Raylio Group signed a strategic cooperation agreement to jointly build a laboratory, promoting the integration of industry, academia, and research as well as the transformation of innovative achievements. The two parties will engage in long-term cooperation in areas such as technical strategic consulting, technological innovation, development of new products, and talent cultivation, driving the upgrading of healthcare technology.
09
Strategic Cooperation Ping An Health Insurance, Peking University Medical Group, and Jingeng Hospital Sign Agreement to Explore New Pathways for "Medical-Insurance Collaboration"
On October 21, Ping An Health Insurance, Peking University Medical Group, and Jingeng Hospital signed an agreement to deepen cooperation in areas such as healthcare, medical insurance collaboration, including discipline co-construction, expert sharing, medical-insurance synergy, and to establish a medical service center.
10
Boston ScientificTwo Medical Devices Approved for Marketing by FDA
Recently, can be integratedFARAWAVE NAV Ablation Catheter and Faraview Software Receive FDA Approval
11
Wanhua Chemical and Blue Sail Medical Sign Strategic Cooperation Agreement
Recently, Bluestar Medical and Wanhua Chemical signed a strategic cooperation agreement at Wanhua Chemical's Cishan headquarters. The two parties have maintained a friendly and in-depth cooperative relationship in the research and development and market cultivation of polyurethane gloves. Through this agreement, Wanhua Chemical and Bluestar Medical will continue to expand the scope of cooperation, focusing on the application of chemical new materials such as polyether block amide, nylon, and polycarbonate in the medical device field, further deepening collaboration to promote the construction of a complete and resilient healthcare industry ecosystem. The jointly inaugurated Innovation Lab will also provide an efficient and open communication platform for both parties. The lab will rely on Wanhua Chemical's profound accumulation in the field of chemical new materials, combined with Bluestar Medical’s professional advantages in the medical device industry, laying a solid foundation for the joint research and development of new materials and technologies in the healthcare field.
12
Medtronic Core Products Class I Recall
Recently, according to an announcement by the FDA, the batteries of Medtronic's recalled MiniMed 600 and 700 series insulin pumps have been classified as a serious Class I recall event, meaning that using these devices could cause severe injury or death. In fact, Medtronic had long recognized the battery life issue with the insulin pumps. From January 2023 to September 2024, Medtronic received a total of 170 reports of hyperglycemia (>400 mg/dL) and 11 cases of diabetic ketoacidosis in the United States, all potentially related to this issue. According to the FDA’s device recall database, Medtronic's Class I recall event in October involved approximately 785,000 system products. In response, Medtronic sent two warning letters to customers in July and October this year, notifying clients of its diabetes devices to follow built-in alerts and battery status warnings. The company also stated that if customers observe changes in the pump's battery life, they should contact Medtronic.
13
Roche Renews Cooperation Agreement with Hitachi
Recently, Roche and Hitachi High-Tech officially renewed their cooperation agreement, committing to deepen their partnership for at least another decade. The two companies plan to launch new products in the coming months, including the cobas c 703 and cobas ISE neo analysis units, as part of the cobas pro integrated solution. These innovations aim to enhance laboratory testing capabilities, providing accurate and timely diagnostics for millions of people worldwide. Additionally, the two parties plan to introduce the cobas mass spectrometry solution by the end of this year, integrating fully automated mass spectrometry into daily laboratory use, making this gold-standard technology more accessible for various clinical applications globally. These innovations are not only transforming how diagnostics are delivered but also strengthening the sustainability and resilience of healthcare systems.
14
GE Healthcare Launches New Ultrasound System
Recently, GE Healthcare Launched the New Versana Premier Ultrasound SystemRecently, GE Healthcare launched the new Versana Premier ultrasound system. This newly released Versana Premier system by GE Healthcare features multiple intelligent upgrades, providing doctors and medical institutions with more convenient and efficient diagnostic support. By integrating various AI technologies, GE Healthcare's Versana Premier system demonstrates high innovation and efficiency improvement in the field of ultrasound imaging. These AI technologies not only significantly enhance the efficiency of ultrasound diagnosis but also help doctors reduce the risks of misdiagnosis and diagnostic delays. Through innovations in AI functions, GE Healthcare is redefining the process of ultrasound diagnosis, showcasing the enormous potential of AI in the field of medical imaging.
15
Abbott's global sales reached75.4 billion
Recently, Abbott announced its third-quarter financial report. The momentum of Abbott's diversified business model continued into the third quarter of 2024, with global sales of its base business reaching $10.6 billion (approximately 75.472 billion RMB), representing an organic growth of 8.2% and a reported sales growth of 4.9%. The medical device sector achieved double-digit growth, with organic growth at 13.3% and reported growth at 11.7%. Notably, diabetes care performed exceptionally well (organic growth of 19.1%, reported growth of 17.1%), with continuous glucose monitor sales reaching $1.6 billion. Sales in structural heart (organic growth of 16.5%, reported growth of 14.6%) and heart failure (organic growth of 14.4%, reported growth of 14%) also saw significant increases.
16
Abbott Launches a Groundbreaking Clinical Trial
On October 24, Abbott announced the launch of a first-of-its-kind clinical trial — the TEAM-HF trial, which incorporates two of Abbott's major products in heart failure: the CardioMEMS HF System and the HeartMate 3 Left Ventricular Assist Device (LVAD). This trial plans to recruit approximately 850 patients across 75 sites globally.
17
Two Products Developed and Produced by MacroLux Successfully Approved for Marketing
On October 16, Decypher™ (Tianwen™), the Intravascular Ultrasound (IVUS) diagnostic device, and Outsight® (Lijian®), the single-use intravascular ultrasound diagnostic catheter, developed and manufactured by Shenzhen Minimally Invasive Trace Medical Equipment Co., Ltd., successfully received approval from the National Medical Products Administration (NMPA) for market launch in China (NMPA Approval No. 20243062024, NMPA Approval No. 20243062034).
18
National Medical Products Administration Releases "Tissue Engineering Medical Devices Fibroin Protein》Pharmaceutical Industry Standard
Recently, the National Medical Products Administration released the pharmaceutical industry standard "Tissue Engineering Medical Devices: Silk Fibroin," providing clear technical specifications for the application of silk fibroin in the medical device field. This standard covers requirements for the physical and chemical properties of silk fibroin, as well as regulations on labeling, packaging, transportation, and storage, ensuring its safe and effective use in medical devices. The release of this standard fills an industry gap and establishes new norms for the application of silk fibroin in medical aesthetics and regenerative medicine.
19
Six Major Centers of the National Medical Products Administration Land in Yizhuang
Recently, the Information Center of the National Medical Products Administration (NMPA) was inaugurated at Beijing's BioPark, marking the full establishment of all six core centers of the NMPA in Beijing Economic-Technological Development Area (Beijing ETDA). These six centers, representing the core operational departments of the NMPA, bring together regulatory resources in Yizhuang to provide robust support for high-quality development in biotechnology and the broader healthcare industry through administrative approvals, qualification certifications, and more. The six core centers of the NMPA include: the Center for Drug Evaluation, the Center for Food and Drug Inspection, the Drug Evaluation Center (National Center for Adverse Drug Reaction Monitoring), the Center for Medical Device Evaluation, the Administrative Matters Acceptance Service and Complaint Reporting Center, and the Information Center (China Food and Drug Administration Data Center). The Center for Drug Evaluation is responsible for conducting technical reviews of drug registration applications in accordance with relevant regulations on drug registration management. The Center for Medical Device Evaluation handles the acceptance and technical evaluation of applications for domestically produced Class III medical devices and imported medical devices.
20
Wuhan Qiaokou Tongji Health City Accelerates the Transformation of Scientific and Technological Achievements
Recently, by the Qiaokou District People's Government of Wuhan City and the gold control platform of Hubei ProvinceThe unveiling and signing ceremony for the biomedicine innovation and development industry fund, established in collaboration with "MacroLux," was held at the Tongji Industrial Science and Technology Innovation Center in Wuhan. During the signing ceremony, the Qiaokou District People's Government announced the 2024 Qiaokou Health Industry Strategy, introducing the “Ten Initiatives” to optimize the health industry development ecosystem. The Hubei Provincial Drug Administration, the Hubei Provincial Healthcare Security Administration, and Tongji Hospital jointly signed a cooperation agreement to support the development of Qiaokou’s health industry. Additionally, the fund signed a strategic cooperation agreement with Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology. Both parties plan to carry out comprehensive cooperation in areas such as investment and transformation of scientific research achievements, construction of achievement transformation platforms, talent cultivation, and exchange. They agreed to establish an exclusive expert advisory team for the "fund," set up a joint meeting system, and collaboratively improve the screening mechanism for achievement transformation projects.
21
Chongqing Drug Administration and Meituan Sign Strategic Cooperation Agreement on Quality and Safety Supervision of Online Sales of Drugs and Medical Devices
Recently, to further strengthen the quality and safety supervision of pharmaceuticals and medical devices in online sales, promote social co-governance, and crack down on illegal activities related to the online sale of pharmaceuticals and medical devices, ensuring public safety in medication and device usage, the Chongqing Municipal Medical Products Administration signed a strategic cooperation agreement on quality and safety supervision with Meituan Medical & Health. Meituan Medical & Health is an important platform for the public to purchase pharmaceuticals and medical devices online, playing a significant role in assisting with the quality and safety supervision of these products and ensuring their quality. The Chongqing Medical Products Administration will provide support in policy and regulation training, data sharing of pharmaceuticals and medical devices, regulatory risk alerts, and pre-warning of merchant violations, making further efforts to continuously create a top-tier business environment.
22
Shanghai Medical Products Administration Informationization Project SelectedTypical Cases of Intelligent Supervision in 2024
Recently, the "2024 Pharmaceutical Intelligence Development Conference," hosted by the Information Center of the National Medical Products Administration, released 10 intelligent supervision typical cases and 5 intelligent collaboration governance typical cases. The "Shanghai Drug Safety Mobile Supervision Application System" was selected as one of the top 10 intelligent supervision cases, while "Insilico Medicine’s Artificial Intelligence Platform Pharma.AI" and "Shanghai Pharmaceutical Biochemical Co.’s Industrial Internet Platform" were selected as intelligent collaboration governance typical cases. The "Shanghai Drug Safety Mobile Supervision Application System" is a mobile supervision system developed by the Shanghai Drug Administration. Focusing on improving regulatory efficiency, it covers 13 categories of regulatory operations for drugs, medical devices, and cosmetics. Utilizing technical means such as data sharing, GPS positioning, shared credit records, and electronic signatures, the system simplifies regulatory processes, structures inspection data, supports intelligent knowledge bases, and provides precise information support, significantly reducing preparation and data entry time for inspections, offering a more convenient and efficient intelligent supervision method for drug safety oversight.
23
Shanghai Yangpu Promotes High-Quality Development of the Life Health Industry
Recently,"2024 Value-Based Healthcare Conference of the Medical Community and the 5th Taishan Award Ceremony" Held in Yangpu District, Shanghai. The Yangpu District People's Government of Shanghai stated that it is currently laying out four future industry tracks, including artificial intelligence, life health, green low-carbon, and technology services. In terms of the life health industry, Yangpu is a region rich in medical resources in northern Shanghai, with medical institutions at all levels, including a group of outstanding tertiary hospitals, seven district-level community hospitals, and 12 community health service centers. The district also hosts a concentration of top talents, including academicians of the Chinese Academy of Sciences and Chinese Academy of Engineering, as well as high-end professionals from home and abroad, from prestigious institutions such as Fudan University, Tongji University, and the Naval Medical University. In the high-end medical sector, Yangpu has the USST Science Park, a municipal innovation platform in Shanghai aimed at the industrialization of medical devices. The Shanghai High-End Medical Equipment Innovation Center leverages the academic strengths of the University of Shanghai for Science and Technology, focusing on high-end imaging diagnostic equipment, high-performance in vitro diagnostics, medical robots, and other industrial clusters.
24
NMPA CMDE Announces Review Results of Special Review Applications for Innovative Medical Devices
Recently, according to the NMPA's "Special Review Procedure for Innovative Medical Devices," the Innovative Medical Device Review Office organized relevant experts to review applications for special review. The following application projects are proposed to enter the special review process and are now being publicized. The public announcement period is from October 18, 2024, to November 1, 2024. The product names are as follows: Liver Hypothermic Perfusion System, Cardiac Pulsed Field Ablation Catheter, Wrist Joint Prosthesis System, Medical Carbon Dioxide Contrast Pressure Injection Kit, Interventional Left Ventricular Assist System, Single-Use Cardiac Pulsed Field Ablation Catheter, and Percutaneous Surgery Navigation and Positioning System.
Note: The information in this article is compiled based on online news.
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