Weekly Medical Device News Roundup (June 24 – July 1): Funding, FDA Approvals, and Strategic Collaborations
TowardPi
High-end Ophthalmic Medical Device Developer
Aidite
Zirconia Dental Ceramic Manufacturer
BVLASER
Medical Aesthetic Device Developer
01
Ophthalmic Medical Device Company TowardPi Completes RMB 200 Million Series D Financing
Recently, TowardPi, a leading enterprise in China's high-end ophthalmic medical device industry, completed its D-round financing of 200 million yuan. This round of financing was led by Matrix Partners, with participation from GaoTJ Investment and other institutions. Established in 2017, TowardPi’s core technology originates from the transformation of scientific achievements at Tsinghua University, and its core technical team consists of dozens of Tsinghua teachers, students, and alumni. Since its founding, the company has achieved breakthroughs in multiple categories of high-end ophthalmic devices through the vertical integration of clinical ophthalmic needs, innovative system functions, and high-performance upstream components. TowardPi's ophthalmic OCT products have captured a 27% market share in public hospitals in China, ranking first in the domestic market. It is also the first Chinese enterprise to achieve a "full product line" layout in high-end ophthalmic medical devices.
02
Aidite, the First Stock of Dental Instruments, Goes Public
Recently, A-share market welcomed the first IPO in the dental equipment sector. Aidite (Qinhuangdao) Technology Co., Ltd. (referred to as "Aidite," 301580.SZ) officially listed on the ChiNext Board of the Shenzhen Stock Exchange. The opening price was 99.99 yuan, once rising over 122%, with a market value surpassing 6.5 billion yuan. As one of the largest producers of zirconia ceramic blocks for dentures in China, Aidite has been committed to the independent research, production, and sales of internationally competitive zirconia ceramic blocks and other dental restoration materials since its establishment in 2007. After years of development, the company has grown into a leading provider of dental restoration materials and digital equipment in China, forming three major product categories: dental zirconia, dental glass ceramics, and dental resin materials, covering three key industry chain segments: prevention, restoration, and orthodontics.
03
Chinese-Made Medical Beauty Device Manufacturer BVLASER Completes Tens of Millions of Yuan in Series B Financing
Recently, BVLASER (Suzhou Bofu Laser Technology Co., Ltd.) announced the completion of a multi-million yuan Series B round of financing. This round of financing was invested by Daxing Airport Economic Zone Development Fund, managed by Beijing Xinhangcheng Fund Management Co., Ltd. ("Xinhangcheng Fund Company"), a subsidiary of Beijing Xinhangcheng Holding Co., Ltd. The proceeds from this round of investment will be used for the research and development and registration of new products, the expansion into overseas markets and brand building, the preliminary establishment of domestic channels, and accelerating the global layout of BVLASER's self-developed equipment. With over a decade of deep cultivation in the photoelectric medical aesthetics sector, BVLASER is committed to independent innovation and mastering core R&D technologies. The company’s current product line includes 1064nm and 532nm picosecond lasers, ND:YAG Q-switched lasers, 755nm long-pulse Alexandrite lasers, 2940nm Erbium lasers, and 1927nm Thulium lasers. Its products have been exported to more than 70 countries and regions worldwide.
04
Driven by both policy and capital, the spectrometer market in China is expected to reach $30 billion.
Recently, Suzhou Weibang Zhendian and Wuxi Xunjie Guangyuan have respectively completed A+ round and over 100-million-yuan financing, which will be used for the commercialization and R&D of spectroscopic instruments. Driven by policies and capital, China's spectroscopic instrument market is expected to reach a scale of 3 billion US dollars, with the domestically produced high-end spectroscopic instruments being the key to development. Both Weibang Zhendian and Xunjie Guangyuan have profound expertise in spectroscopy technology, providing innovative solutions to the market.
05
TowardPi Medical Completes RMB 200 Million Series D Financing, Tsinghua's Indigenous Technology Continues to Lead Innovations in Ophthalmic Equipment
Recently, TowardPi, a leading enterprise in China's high-end ophthalmic medical device industry, completed its D-round financing of 200 million yuan. This round of financing was led by Matrix Partners, with participation from GaoTJ Investment and other institutions. Established in 2017, TowardPi’s core technology originated from the transformation of scientific achievements at Tsinghua University, and its core technical team consists of dozens of Tsinghua teachers, students, and alumni. Since its founding, the company has achieved breakthroughs in multiple categories of high-end ophthalmic equipment through the vertical integration of clinical ophthalmic needs, innovative system functions, and high-performance upstream components.
06
Orthopedic Giant's Latest Surgical Robot Approved by FDA
Recently, Global Medical, one of the top ten global orthopedic device companies, announced that its new Excelsius Flex orthopedic surgical robotic system for knee surgeries has received FDA approval for stereotactic positioning. Additionally, the expanded indications for the ExcelsiusHub system have also been approved by the FDA. The Excelsius Flex system is integrated into the first-class Excelsius ecosystem to assist surgeons in primary total knee arthroplasty by guiding resections according to implant placement plans. Global Medical stated that it is currently ramping up production of the surgical robot and expects a commercial launch in the fourth quarter, extending its innovative technology into the $15 billion joint reconstruction surgery market.
07
Globus Medical's New Excelsius Flex Orthopedic Surgical Robotic System Receives FDA Approval for Stereotactic Knee Surgery
Recently, Global Medical's latest Excelsius Flex orthopedic surgical robotic system received FDA approval for stereotactic knee surgery, while the indications for the ExcelsiusHub system were also approved. This system assists surgeons in performing total knee arthroplasty and is planned for commercial release in the fourth quarter to expand its application in the joint reconstruction surgery market. As one of the leading companies in China's in vitro diagnostics industry, we are committed to building the best in vitro diagnostics testing platform. We currently have a biochemical testing system, a coagulation testing system, and a blood type testing system. Years of stable development and continuous improvement have established an extensive marketing and service network across the globe.
08
China Successfully Develops the World's First Open-Source "On-Chip Brain-Computer Interface" Intelligent Interaction System MetaBOC
Recently, the team from Tianjin University's Brain-Computer Interface and Human-Machine Symbiosis Haihe Laboratory, in collaboration with Southern University of Science and Technology and other teams, co-developed the world's first open-source "on-chip brain-computer interface" intelligent interaction system, MetaBOC. This system enables cultured "brains" to autonomously control robots in tasks such as obstacle avoidance, tracking, and grasping, completing a variety of brain-inspired computing tasks. The cultured "brain" serves as the command center of the system. The team was the first internationally to confirm the role of physical fields in promoting the growth and development of human-derived brain organoids, clarifying the principle and mechanism of low-intensity focused ultrasound in brain modulation. This provided MetaBOC, the on-chip brain intelligent interaction system, with a cultured "brain" that has a stronger foundation for intelligence. The research findings were recently published in the international journal *Brain* in the field of brain science.
09
Changde Medical Creates Comprehensive Solutions for Peripheral Interventional Devices
Recently, Changde Medical received investments from multiple well-known institutions, committing to provide a complete solution for peripheral interventional devices. The company is led by the former president of a listed company and has developed more than ten products, focusing on blood vessels and related fields with extensive experience in R&D and commercialization. The funds will be used to advance product development, registration, and commercialization processes, enhancing market competitiveness.
10
Deepening the Full Life Cycle Cooperation of Medical Devices: Juyi Technology and Aipeng Medical Sign Strategic Cooperation Agreement
Recently, JoyMed Technology and Apon Medical signed a strategic cooperation agreement to deepen collaboration around the entire lifecycle of medical devices, jointly address industry challenges, and promote the development of the healthcare industry. Both parties will strengthen their business cooperation to achieve common development. Through this strategic agreement, Apon Medical and JoyMed Technology will focus on various aspects of the medical device lifecycle, leveraging their respective strengths to establish a strategic cooperation framework. Through this partnership, both companies aim to foster mutual growth, enhance in-depth business collaboration, jointly face new external challenges, and contribute to the advancement of the healthcare industry.
11
Globus Medical's New Excelsius Flex Orthopedic Surgical Robotic System Receives FDA Approval for Stereotactic Knee Surgery
Recently, Global Medical's latest Excelsius Flex orthopedic surgical robot system received FDA approval for stereotactic knee surgery, and the indications for the ExcelsiusHub system were also approved. The system assists surgeons in performing total knee arthroplasty and is planned for commercial release in the fourth quarter to expand its application in the joint reconstruction surgery market.
12
Daan Gene Subsidiary Obtains a Medical Device Registration Certificate
Recently, Da'an Gene announced that its subordinate holding subsidiary, Guangzhou Darui Biotechnology Co., Ltd., has obtained a medical device registration certificate issued by the National Medical Products Administration. The name of the medical device is: Hepatitis C Virus Antibody (HCV) Control, Registration Certificate No.: GuoXieZhuZhun 20243401117. Valid from the date of approval until June 17, 2029. Intended use: For threshold correction in qualitative testing of Hepatitis C Virus Antibody.
13
Jinan Municipal Supervision Bureau Conducts Supervision and Inspection of Third-Party Logistics Enterprises for Medical Devices
Recently, in order to strengthen the supervision and management of the circulation of medical devices, the Jinan Market Supervision Administration organized an inspection of enterprises that specifically provide transportation and storage services for medical devices. They provided guidance on the situation regarding third-party storage and distribution services, requiring enterprises to implement their main responsibilities and fully comply with the new regulatory requirements. Currently, there are nearly 20 third-party logistics enterprises in Jinan that specifically provide transportation and storage services for medical devices. Third-party logistics plays a very important role in the circulation of medical devices. Professional and intensive services not only reduce costs and improve efficiency but also better ensure the quality and safety of medical device products. These services improve the circulation chain of medical devices from production, operation to use, and can more effectively guarantee the safe use of medical devices by the public.
14
NMPA Seeks Public Comments on the Guiding Principles for On-site Inspection of Medical Device Operation Quality Management Standards (Draft for Comments)
Recently, in order to standardize and guide the on-site inspection of the Quality Management Norms for Medical Device Operation, the National Medical Products Administration has drafted the "Guiding Principles for On-site Inspection of the Quality Management Norms for Medical Device Operation (Draft for Comments)" and is now soliciting public opinions. It mentions that during the on-site verification of the operation permits (including changes and renewals) of medical device operating enterprises, if all applicable items meet the requirements or can be rectified on the spot, the inspection result will be "Pass the Inspection"; if the number of non-conforming key items (marked with “※”) ≤10% and the number of non-conforming general items (unmarked) ≤20%, the inspection result will be "Rectification within a Time Limit"; if the number of non-conforming key items >10% or the number of non-conforming general items >20%, the inspection result will be "Fail the Inspection".
15
Lingang New Area Medical Device Innovation Center Inaugurated
Recently, the Launch Ceremony of the Lingang New Area Medical Device Innovation Center and the International Medical Technology Cooperation Exchange Conference were held. Multiple institutions have registered at the Medical Device Innovation Center in the new area. Medical technology-related projects from Canada, Belarus, Uzbekistan, and other countries signed agreements to establish a presence on-site. Universities, medical schools, and hospitals from multiple countries signed cooperation agreements with the Lingang New Area Medical Device Innovation Center focusing on "innovation transformation, education and training, and international exchange." The unveiling of the Lingang New Area Medical Device Innovation Center aims to build an open, full industrial chain, end-to-end, one-stop innovation service platform, widely attracting global medical science and technology innovation projects and top talents, while actively promoting the overseas expansion of high-quality medical device products and enterprises produced in China.
Note: The information in this article is compiled based on online news.
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