【Key Policies】The State Drug Administration issued the "2024 Medical Device Industry Standard Formulation and Revision Plan Project" to promote the high-quality development of the medical device market.
On April 11, the State Drug Administration issued the "2024 Medical Device Industry Standard Formulation and Revision Plan Project" (hereinafter referred to as the "Plan Project").
In order to implement the "Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building" issued by the General Office of the State Council, the relevant requirements of the "14th Five-Year Plan" National Drug Safety and Promotion of High-quality Development, and in accordance with the deployment of the formulation and revision of medical device industry standards of the State Food and Drug Administration, the 2024 medical device industry standard formulation and revision plan is hereby issued to you, and the relevant requirements are notified as follows:
1. The relevant provincial (municipal) drug administration should attach great importance to and conscientiously organize the standard undertaking units in their respective administrative regions to carry out the work of standard formulation and revision, strengthen supervision and management, and ensure that all tasks are completed as required.
2. The Device Standardization Center of the State Food and Drug Administration shall conscientiously organize and coordinate the technical committees, working groups and technical focal points of various medical device standardization (sub-committees), carry out standard formulation and revision work in strict accordance with the "Management Specifications for the Formulation and Revision of Medical Device Standards", strengthen business management and inspection guidance, and ensure the quality and level of standards.
3. The technical committee, working group and technical focal point of medical device standardization (sub) that undertake the task of standard formulation and revision should do a good job in the organization of standard drafting, verification, soliciting opinions and technical review, etc., and should conduct extensive research and in-depth research to ensure the scientificity, rationality, applicability and compliance with relevant policy requirements of the technical content of the standard.
Comments: With the continuous progress and innovation of medical technology, the medical device industry has shown a vigorous development trend, the market scale continues to expand, and the product variety is becoming more and more abundant. As of 2023, the size of the mainland medical device market will reach 1,035.8 billion yuan, a year-on-year increase of 10.18%.
However, just like the two sides of the coin, the rapid expansion of the market has also exposed a series of problems. The instability of product quality and the frequent occurrence of potential safety hazards all bring potential threats to the life safety and health of patients. At the same time, with the continuous emergence of new technologies and new materials, the old standards may no longer meet the new development needs. Therefore, timely formulation and revision of standards is of great significance to guide technological innovation, improve product quality, and ensure patient safety. The "Plan Project" clarifies the formulation and revision goals in 2024, and a total of 98 medical device industry standards will be revised or formulated. Of these, 90 products are related to recommended standards, which will provide clearer guidance to the market and promote the steady improvement of product quality, while 8 products are related to mandatory standards, which will ensure that safety performance in key areas is strictly controlled to protect patient safety.
Through standardized means, the "Plan Project" aims to comprehensively strengthen the quality control of medical device products, improve user experience and safety, and inject strong impetus into the high-quality development of the medical device industry. At the same time, the policy unifies the technical standards and specifications of the medical device industry, promotes the technological progress and innovation of the industry, effectively enhances the competitiveness of the medical device industry, and promotes the healthy development of the industry. This not only reflects the government's great importance to the development of the medical device industry, but also demonstrates the government's firm determination to protect public health and maintain market order.
Figure 1: China's medical device market size from 2019 to 2023
Source: China Association for Medical Devices Industry and Zhiyan Consulting
【Key Policies】The Hunan Provincial People's Government issued the "Hunan Provincial Implementation Plan for Promoting Large-scale Equipment Renewal and Consumer Goods Trade-in" to promote the upgrading of equipment and information facilities of medical and health institutions
On April 12, the Hunan Provincial People's Government issued the "Hunan Province Implementation Plan for Promoting Large-scale Equipment Renewal and Consumer Goods Trade-in", proposing to carry out iterative upgrading of medical and health institutions' equipment and information facilities, and promote medical and health institutions to eliminate and update medical equipment and information facilities that have reached their service life, are incomplete, have backward performance, and affect safety according to their functional positioning, technical level, discipline development and public health needs.
Encourage qualified medical and health institutions to speed up the renewal and transformation of medical equipment such as medical imaging, radiation therapy, remote diagnosis and treatment, and surgical robots. Promote the upgrading of information facilities such as servers, terminals, network equipment, and security equipment in medical and health institutions, and further improve the level of hospital data interconnection, network information and data security, and hospital information standardization.
【Key Events】Transcript of the 2024 Special Press Conference on the Investigation and Handling of Cases in the Field of People's Livelihood "Iron Fist" Action
On April 8, the State Administration for Market Regulation held a special press conference on the 2024 "Iron Fist" action for the investigation and handling of cases in the field of people's livelihood. At the press conference, Gu Baozhong, market inspector of the Advertising Supervision Department of the State Administration for Market Regulation, proposed that maintaining the order of the advertising market in key areas of people's livelihood such as medical treatment, drugs, medical devices, and health food is of great significance for protecting the safety of people's lives and property and safeguarding the legitimate rights and interests of consumers. The State Administration for Market Regulation has always adhered to the concept of supervision for the people, and has continued to play an "iron fist" in response to the chaos of advertising of "miracle doctors" and "miracle medicines" that have been reflected by the masses. In 2024, the State Administration for Market Regulation will continue to pay close attention to the hot spots of people's livelihood, organize and carry out special actions for advertising supervision in the field of people's livelihood nationwide, and severely crack down on false and illegal advertisements in the fields of medical treatment, medicine, health food, medical devices, education and training, which are concentrated in the society and closely related to the people's lives, effectively solve the problems of the people's urgency, hardship and hope, and continue to purify the advertising market environment.
【Key Event】Beijing Friendship Hospital is the world's first monocular 3D endoscopic imaging system
On April 9, in the examination room of the Digestive Endoscopy Center of Beijing Friendship Hospital Xicheng Branch, Sun Xiujing, chief physician of the Digestive Center of Beijing Friendship Hospital affiliated to Capital Medical University, wore special 3D glasses and completed colonoscopy surgery for a patient in only ten minutes. The reason why the operation is fast is due to the world's first monocular 3D imaging system that can be used for digestive endoscopy, which is jointly developed by the National Key Laboratory of Digestive Health and Xinguangwei Medical, which can help doctors find flat microlesions, more accurately judge the condition of lesions, and improve the detection rate of early cancer. "Compared with ordinary 2D colonoscopy, the use of 3D colonoscopy can increase the detection rate of polyps by 1.54 times and the detection rate of adenoma by 1.45 times. Sun Xiujing said.
【Key Event】Shanghai Fengxian accelerated the construction of a new highland for foreign investment, and signed contracts for medical equipment and other projects
On April 9, a special investment promotion event for the manufacturing industry with the theme of "Tide Surge Pujiang Moves the World" was held in Fengxian, Shanghai, to invite foreign-funded enterprises around the world to work together to draw a new chapter of cooperation, promote the comprehensive and high-quality development of Fengxian's economy, society and city in the new development pattern, and write a better future of mutual benefit and win-win results.
At the meeting, nine major projects covering the fields of beauty and health, intelligent manufacturing, biomedicine, medical devices and other fields, such as the R&D and production base of medical devices and the R&D and production base of biomaterials, were signed.
【Key Event】JD Health signed contracts with 19 brands such as Yuyue and Omron to improve supply and service efficiency and drive sustainable and high growth
On April 11, the 89th China International Medical Equipment (Spring) Expo (CMEF) was held in Shanghai. JD Health has signed strategic cooperation with 19 medical device companies, including Yuyue, Omron, Kefu Medical, Philips, Wenwen, Maidster, Oxygen Genie, Xianhe, Chaoya, Yade Medical, and Ruimet, and reached a lot of consensus on improving the supply of all categories of medical devices, omni-channel circulation and global marketing, so as to jointly improve the supply and service efficiency of medical device products, and provide users with more, faster, better and more economical new health consumption experience.
With the rapid development of the medical device industry in China, China has become the second largest medical device market in the world. Giving full play to the value of technology and data innovation and improving the efficiency of supply and service of all categories has become an important direction for many medical device companies to deepen cooperation with JD Health.
Building an industrial ecology of co-construction, sharing, mutual benefit and win-win is an important foundation for the industry to achieve sustainable and high-quality growth. Taking the CMEF exhibition as an opportunity, JD Health will continue to give full play to its capabilities in full-category supply, omni-channel circulation and full-life cycle marketing, and work with more partners in the medical device industry to provide consumers with better and more convenient products and services, and jointly promote the high-quality development of the medical device industry.
【Key Event】The 89th CMEF Exhibition: AI Leads Industrial Upgrading, and Domestic Medical Equipment is Favored by Overseas Customers
On April 14, the 89th China International Medical Equipment (CMEF) Exhibition was successfully concluded in Shanghai. The exhibition brought together nearly 5,000 top brand enterprises from more than 30 countries and regions around the world, bringing the latest products and scientific research results. The AI medical equipment and applications with a sense of cutting-edge technology are particularly eye-catching, which has become the biggest feature of the exhibition, fully demonstrating the latest trend of intelligent development in the medical industry.
At the exhibition, a number of companies exhibited their latest AI medical equipment. At the booth of Hangzhou Deshi Biotechnology Co., Ltd., the pioneer of global AI chromosome karyotype analysis technology, the cytogenetic intelligence laboratory solution independently developed by the domestic brand and the efficient and intelligent chromosomal karyotype accurate diagnostic equipment recognized as the "first set in the world" attracted many industry onlookers. The core product is based on the self-developed AI algorithm, which breaks through the problem of intelligent high-speed scanning and intelligent assisted analysis of chromosome karyotype, and realizes intelligent and efficient chromosomal karyotype assisted analysis for the first time in the world, which can quickly and accurately assist in the diagnosis of thousands of chromosomal abnormalities, and the issuance time of clinical report for chromosome karyotype analysis is shortened from about 30 days to 4-7 days, and the human consumption is reduced to one-seventh to one-tenth of the traditional one-tenth of the traditional one-tenth of the human consumption, which greatly improves the work efficiency of clinical medical treatment and wins the unanimous affirmation of the industry.
Domestic high-end medical equipment with independent research and development of scientific and technological innovation, breaking through the foreign "neck" technology, not only to promote the localization process of high-end medical equipment, this appearance at the CMEF exhibition attracted many overseas customers to watch and favor, on-site expression of further cooperation intentions. The relevant person in charge of Deshi Biotech said: "China's intelligent manufacturing is favored by overseas customers, and it is the right time for the brand to go overseas. Domestic innovative technology has contributed AI solutions to the global medical and health field, and the positive feedback and cooperation intentions of overseas customers are not only a recognition of the technical advantages of the products, but also a strong proof of the rise of China's intelligent manufacturing on the global stage. ”
With its intelligence, high efficiency, and accuracy, AI medical devices are reshaping the productivity of the medical industry. These devices are equipped with algorithmic systems that use deep learning and big data analysis to quickly and deeply understand diseases and provide accurate decision support for doctors. From the grand occasion of the exhibition, AI medical equipment covers multiple scenarios such as experiment, diagnosis, treatment, and rehabilitation, from intelligent guidance to intelligent image recognition to surgical robots, and then to personalized treatment plans, the application of AI is changing the face of medical services at an unprecedented speed and helping to improve the quality and efficiency of medical services.
With the wide application of AI medical equipment, it is believed that the efficiency of the medical industry will be effectively improved in the future, so that high-quality and efficient medical services can benefit a wider range of people.
【Key Enterprise】A wholly-owned subsidiary of Guoke Hengtai landed in Zhengzhou
On April 12, Henan Guoke Hengxuan Medical Technology Co., Ltd. was established, the legal representative is Wang Fa, with a registered capital of 10 million yuan, and its business scope includes the sales of Class I and Class II medical devices, the retail of computer software and hardware and auxiliary equipment, computer system services, artificial intelligence basic software development, supply chain management services, software development, etc. Shareholder information shows that the company is wholly owned by Guoke Hengtai (301370).
On February 29 this year, Guoke Hengtai announced that after deliberation and approval by the board of directors, it was decided to set up wholly-owned subsidiaries in Henan Province, Hebei Province, Liaoning Province, Hainan Province and other places, and the registered capital of the four subsidiaries was 10 million yuan. Guoke Hengtai said that the proposed establishment of a subsidiary is the company's business development needs, in line with the company's strategic development plan, which is conducive to the company to actively explore and make full use of the market, enhance the company's core competitiveness and comprehensive profitability, expand market share, and promote the development of the company's related business segments.
【Key Enterprise】China Aerospace Science and Technology Corporation signed a strategic cooperation agreement with China Resources Pharmaceutical Commercial Group Medical Device Co., Ltd. to jointly build a highland for domestic high-end medical equipment industry
On April 14, Beijing Institute of Precision Electromechanical Control Equipment of the First Academy of China Aerospace Science and Technology Corporation signed a strategic cooperation agreement with China Resources Pharmaceutical Commercial Group Medical Devices Co., Ltd., and the two sides will give full play to their respective advantages and resource accumulation to jointly promote the construction of domestic high-end medical equipment industry highland. According to the content of the cooperation, the two sides will actively explore diversified cooperation models in the development of medical device products and the establishment of marketing systems, so that each other's technical resources and market resources resonate at the same frequency, further accelerate the transformation of technological achievements, quickly establish market sales channels, and give full play to the synergistic effect of industrial resources.
【Key Enterprise】Sanxin Medical: The blood leakage monitor of the subsidiary passed the review of innovative medical devices
On April 8, Jiangxi Co-vitide Biotechnology Co., Ltd. (Co-vitide), a subsidiary of Sanxin Medical, received the "Jiangxi Province Class II Medical Device Innovative Product Registration Review Result Form" issued by the Jiangxi Provincial Food and Drug Administration, and its self-developed product "Blood Leakage Monitor" was approved for the registration and review of Class II medical device innovative products in Jiangxi Province.
According to the announcement, the blood leakage monitor consists of a monitoring patch and a monitor. The monitoring sticker includes the laying and cable, and the monitor includes the host, the transmitter and the power adapter. The product is used for monitoring and alarming blood leakage at the puncture site of patients, which can timely detect the bleeding at the puncture point and the slippage of the fistula needle during hemodialysis, reduce the probability of medical accidents, improve the safety of hemodialysis and patient satisfaction, and have significant clinical application value.
According to the announcement, coltan focuses on the research and development of vascular access and peripheral vascular intervention-related medical devices, and after the blood leakage monitor is identified as an innovative medical device, it will be given priority in the follow-up application process for innovative medical device registration, the registration cycle of the product will be effectively shortened, the speed of listing will also be accelerated, and it is expected to provide safe and efficient clinical solutions for hemodialysis after marketing.
【Key Enterprise】Sony unveiled its precise imaging solution at CMEF to accelerate the transformation of localization strategies
On April 11, the 89th China International Medical Equipment Fair (hereinafter referred to as CMEF) officially opened in Shanghai, and Sony brought the recently released 55-inch 4K 3D/2D new medical LCD monitor to bring new medical monitoring technology to the industry.
As a highlight of Sony's booth, Xu Linxin, marketing manager of the medical industry of Sony's electronics and system headquarters, introduced that Sony combined HDR technology with medical treatment for the first time in its medical products/solutions, realizing 4K HDR from shooting and transmission to the full link of display, 4K 3CMOS native module with 4K monitor faithfully restores what the human eye sees, ensuring accurate display of intraoperative images, but no exposure and no reflection, to ensure the safety of surgery.
A native 4K 1/3-inch 3CMOS sensor with a 4K 3CMOS native module for high sensitivity. Its clarity reaches 2000TVL, supports HDR, can accurately restore what the human eye sees, and has excellent color reproduction capabilities.
At this CMEF exhibition, Sony relied on excellent image quality, advanced imaging technology and rich product portfolio to bring a variety of innovative new medical technologies represented by 4K medical LCD monitors to the industry. It is foreseeable that with the continuous deepening of the localization strategy, Sony will usher in a different future in the Chinese medical device market.
【Key Enterprises】To create and improve ultrasound solutions, Xiangsheng medical ultrasound equipment was unveiled at the International Medical Equipment Fair
On April 11, the 89th China International Medical Equipment Fair (hereinafter referred to as CMEF) officially opened in Shanghai.
Since its establishment, Xiangsheng Medical has adhered to independent research and development, and is committed to creating perfect ultrasound solutions through continuous technological innovation and in-depth industry insights, so as to provide more accurate and efficient medical services for patients around the world. The blockbuster combination products exhibited this time, the high-end desktop ultrasound SonoMax, the thin and light notebook ultrasound SonoAir, and the small intelligent palm ultrasound SonoEye, mainly provide efficient support for doctors in diagnosis in multiple scenarios, enhance the confidence of diagnosis and treatment, and bring new possibilities and efficiency to medical practice.
It is worth mentioning that Xiangsheng Medical focuses on the perfect integration of AI and medical treatment, and its self-developed artificial intelligence Sono AI has achieved breakthroughs in core technologies such as innovative algorithms and multimodal recognition, forming an ultrasound image AI ecological chain with co-evolution of software and hardware, and algorithms based on deep learning to assist grassroots doctors in diagnosis and improve diagnostic efficiency and accuracy.
Xiangsheng Medical said that at present, under the wave of the times when the country accelerates the development of new quality productivity, promotes large-scale equipment renewal, and encourages domestic substitution, the field of ultrasound equipment in mainland China has ushered in an unprecedented strategic opportunity. Xiangsheng Medical will continue to keep up with clinical needs, continue to explore in digital intelligence empowerment medicine, accelerate the pace of specialization, intelligence and portable miniaturization, demonstrate the strength of scientific research and innovation that continues to break through, continue to surpass, and iteratively update, and provide more accurate and efficient medical services for patients around the world.
【Key Enterprise】MGI released China's first dyeing and measuring gene sequencer with independent intellectual property rights
On April 11, MGI launched the MGISEQ-2000RS FluoXpert multi-omics analyzer at the 89th China International Medical Equipment Fair (CMEF). This is China's first gene sequencer with independent intellectual property rights, integrated pathological staining and sequencing functions, and a sequencer capable of spatial proteomics of pathological tissue sections.
【Key Enterprise】Midea Group's medical business bets on AI+ medical scenarios to empower full-modal medical imaging equipment
On April 11, Midea Medical held the "ForMore.ForOne" strategic upgrade conference and released the "5+2+X" technology strategy, integrating hardware innovation and Al technology through 5 medical-related business entities and 2 group platform research institutes, and establishing a full-chain AIIO medical solution of "outpatient-pharmacy-diagnosis-surgery-hospitalization".
Wei Chang, vice president and CTO of Midea Group, told Jiemian News that "5" refers to five medical-related business entities, including Wandong Medical, Kuka Medical, Midea Biomedical, Swisslog Medical and Midea Building Technology; "'X' is an application solution in different scenarios that represents the hospital scenario promoted by five business entities and two R&D institutions. There are two core points here, one is to make products more competitive through technological innovation and make Midea's medical solutions more differentiated. "This is based on the AIIO solution, which stands for 'AI+Intergration One', emphasizing the concept of AI and medical integration. ”
Wei Chang said that Midea's medical Kunlun AI intelligent imaging (equipment and informatization) platform empowers full-modal medical imaging equipment and opens up the whole clinical process of screening diagnosis and treatment. For example, AI automatic positioning and automatic scanning cover 60% of clinical sites, increasing efficiency by 30%; AI mute technology reduces noise and sound pressure by 86% and improves the comfort of doctors and patients.
【Key Enterprise】Kehua Biotechnology: Obtained two medical device registration certificates
On April 12, Kehua Biotechnology announced that the company received the "Medical Device Registration Certificate" (in vitro diagnostic reagent) issued by the State Drug Administration, and the product names were hepatitis E virus IgM antibody detection kit (chemiluminescence method) and hepatitis B virus core IgM antibody detection kit (chemiluminescence method).
【Key Enterprise】Sinocare Biotech: 2 medical device registration applications were accepted
On April 12, Sinocare Biotech announced that the company recently received the "Notice of Acceptance" for two medical device registration applications issued by the State Drug Administration. The product names are all continuous glucose monitoring systems, and the model specifications are i6/i6e/i6s/i6Pro and H6/h6 respectively.
【Key Enterprise】Shenzhen Akcome Biotechnology Co., Ltd. voluntarily withdrew its application for issuance and listing
On April 8, Shenzhen Akcome Biotechnology Co., Ltd., an IVD (in vitro diagnostic) company that has submitted its form for nearly a year and a half and plans to land on the Science and Technology Innovation Board, voluntarily withdrew its application for issuance and listing, terminating the IPO process of the Science and Technology Innovation Board.
【Key Enterprise】Largev Instrument voluntarily withdrew its application for issuance and listing
Beijing Largev Instrument Co., Ltd. (hereinafter referred to as "Largev Instrument") was announced to terminate the review of the IPO of the Science and Technology Innovation Board, directly due to the application of the company and the sponsor Dongxing Securities to withdraw the application and sponsorship. According to the data published on the official website of the Shanghai Stock Exchange, the IPO application of Largev Instruments was accepted on June 29, 2022, and the first round of inquiries was received and a reply was completed on July 20, 2022. It is worth noting that Largev Instruments has not been at the meeting since the completion of the first round of responses, and the website of the Shanghai Stock Exchange has not published follow-up questions and responses.
【Key Enterprise】The IPO of Aike Medical, an innovative medical device company in the field of neurointervention, was terminated on the Science and Technology Innovation Board
On April 11, according to the official website of the Shanghai Stock Exchange, the IPO review status of the Science and Technology Innovation Board of Aike Medical Devices (Beijing) Co., Ltd. (hereinafter referred to as "Aike Medical") was changed to "terminated" due to the withdrawal of the company's and sponsor's application for issuance and listing.
According to the prospectus (application draft), Aike Medical is an innovative medical device company focusing on the field of neurointervention, which has entered the commercialization stage. As of the signing date of the prospectus, its three core products, Lattice® blood flow directing dense mesh stent, Cosine®71/58 distal access catheter and Sine27 microcatheter, have obtained the registration certificate of Class III medical device and achieved commercialization.
The company originally planned to raise 1.039 billion yuan for the production and construction project of neurointerventional medical devices, the research and development project of neurointerventional medical devices, the construction project of marketing network and supplementary working capital.
【Key Enterprise】Yipin Biotech completed tens of millions of yuan in Series A financing to build a CDMO platform for medical devices
On April 11, Guiyang Yipin Biotechnology Co., Ltd. (hereinafter referred to as "Yipin Biotechnology"), a subsidiary of Yipin (Guiyang) Quality Technology Co., Ltd. (hereinafter referred to as "Yipin Technology"), officially announced the completion of tens of millions of yuan in Series A financing. This round of financing was led by Guiyang Venture Capital, followed by Guiyang Health Investment and Guiyang Baiyun Industry. This round of financing will be mainly used to accelerate the construction of a high-level passive medical device CDMO platform in the Medical Device Industrial Park of Baiyun District, Guiyang City.
As a scarce CRTDMO integrated service organization in the field of IVD reagents and medical dressings, Yipin Biotech has the ability to provide services for the whole process of R&D, testing and testing, and production. At present, the market size of IVD reagents and medical dressings is growing rapidly, and Yipin Biotech is expected to grow rapidly.
Combined with the layout of Yipin Technology in the field of comprehensive preclinical research and CRO services related to all-disciplinary inspection and testing for many years, Yipin Biotech can open up one-stop service capabilities of cooperative R&D, supply chain management, commissioned production, quality system, inspection and testing, animal experiments, clinical trials, and product registration, and provide CRTDMO solutions focusing on passive medical consumables, medical aesthetics and IVD reagents.
As a leading medical device CRO company in China, Yipin Technology will help the company open up the production service capacity after the registration and listing of medical device products through the expansion of Yipin Bio's CDMO business. Previously, Guiyang Venture Capital and Baiyun Industrial Investment (a subsidiary of Baiyun Industrial) have participated in multiple rounds of financing of Yipin Technology.
【Key Enterprise】Jianshi Medical completed a new round of financing of hundreds of millions of yuan, led by Tin Venture Capital
On April 11, Jianshi Medical Technology Group (hereinafter referred to as "Jianshi Medical") announced that it had received a new round of financing of hundreds of millions of yuan, which was led by Tin Venture Capital and Binhu Industrial Group, and followed by well-known medical device industry parties in the United States. It is reported that this round of financing will be used for product research and development, production expansion and subsequent commercial expansion at home and abroad at the Wuxi base of Jianshi.
Founded in 2019, the company has a variety of leading products, and is the first local enterprise in China to be approved for high-tech device products such as electric laparoscopic staplers, antibacterial sutures, intracranial thrombectomy stents, and interventional aortic valves. Up to now, Jianshi's products have entered more than 2,000 large and medium-sized hospitals in China, and the products are exported to Europe, the Americas and South Korea and other international markets. Jianshi Medical has established a number of high-end R&D and production bases in China, and has been equipped with high-level production capacity in terms of manufacturing process and large-scale mass production, benchmarking against the world's advanced medical technology enterprises.
【Key Enterprise】Ruimeng Medical completed tens of millions of yuan in Series A financing, focusing on autonomic nerve detection and intervention technology
On April 12, Ruimeng Medical, which focuses on autonomic nerve detection and intervention technology, completed tens of millions of yuan in Series A financing, which was led by Zijingang Capital and followed by industrial capital such as Haoyiduo. It is understood that this round of financing will be mainly used to increase R&D investment and the construction of automated production lines.
Founded in September 2019, Ruimeng (Shenzhen) Medical Technology Co., Ltd. brings together veterans in the fields of medical devices, health management, mobile Internet, big data processing, etc., to create a new format of medical device R&D and production enterprises, committed to the development and production of PHIS small particle units (professional, wearable, implantable), new medical device Internet of Things products and provide professional intelligent services for disease management.
In January 2023, Raymond Medical's first product, R6000, won the first medical device certificate in China in the field of cardiac autonomic nerve detection equipment. The clinical uses of this product include: cardiac autonomic function detection and assessment, diabetes complication risk assessment, cardiovascular disease analysis and evaluation (vertigo, orthostatic hypotension, etc.). It is mainly suitable for people with diabetes, hypertension, hyperlipidemia, obesity, Alzheimer's disease, epilepsy, etc.
The R6000 adopts the gold standard detection methods recommended by global multi-academic organizations - CARTs reflex test and event HRV heart rate variability analysis, which realizes the standardization, intelligence, wearability and high interaction with users of the detection process. Compared with the current traditional manual inspection, Ruimeng R6000 solves the problem of high dependence on the professionalism of inspectors, greatly saves manpower, and greatly shortens the detection time (from 2 hours to 30 minutes), and improves the detection efficiency. In addition, the standardization of R6000 technology ensures the accuracy and reproducibility of test data, which is expected to promote the popularization of cardiac autonomic nerve testing in clinical examination and research.
One of the main reasons for the lack of long-term, large-sample clinical studies in diabetic autonomic neuropathy is the lack of effective and efficient diagnostic evaluation tools. Raymond R6000 effectively solves this clinical pain point, and also opens up the scientific research direction of CAN diagnosis and treatment. At present, Ruimeng Medical has cooperated with a number of tertiary hospitals in the development of autonomic neuromodulation intervention technology, and realizes autonomic neuromodulation intervention for patients through bioelectric neuromodulation control technology + traditional Chinese medicine acupuncture technology, and the service population has also extended from diabetic patients to patients with hypertension and heart failure.
In 2024, the R6000 will start the admission of 100+ public and private hospitals, and reach cooperation with a number of high-end physical examination centers to reach patients through multiple channels and realize the popularization of CAN early screening. The small particle unit of R6000 has realized wearable and data migration to the cloud, and can be quickly applied to multiple smart medical scenarios in the future, such as in-hospital medical wearable cloud monitoring, social medical cloud monitoring and early warning, remote intervention treatment, special disease and chronic disease management system, pre-hospital emergency monitoring system, etc.
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