Medical Device Weekly Highlights (Jan 6–12): Innovations, Approvals, and Strategic Moves

Jan 14, 2025 08:01 CST Updated 08:01

Sansure Biotech

Provider of Total Solutions for In Vitro Diagnostics

Medtronic

Medical Device Manufacturer

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RainSure SCIENTIFIC CompletedC2 Round Financing for Clinical Registration of Digital PCR Products in China and Overseas

On January 9, RainSure SCIENTIFIC announced the completion of a strategic financing round worth tens of millions of RMB in its Series C2. This round was led by RJ Kangsheng. The funds will primarily be used for domestic and international clinical registration of digital PCR products, promotion in the European market, and the development of new products. RainSure SCIENTIFIC, established in July 2017, specializes in technology development, consultation, transfer, and services within the biotechnology sector. It also engages in the research, production, and sales of biologics, medical devices, laboratory instruments, and bio-instruments. Its main products include digital PCR systems and matched reagent kits, nanoparticle synthesis systems, pharmaceutical LNP systems, and real-time fluorescent quantitative PCR systems. These products have gained widespread acclaim in scientific research and medical fields due to their excellent quality and performance.

Sansure800 Million Yuan Mega Acquisition

Recently, Sansure Biotech Inc. has actively responded to the national call for children's health management and promotion of long-term balanced population development. By leveraging its business advantages in the in vitro diagnostics field as a publicly listed company and Zhongshan Haiji’s strengths in the growth hormone sector, Sansure aims to promote its comprehensive strategic layout of "integrated diagnosis and treatment" and enhance the profitability of the listed entity. Accordingly, Sansure has agreed to acquire 100% equity of Zhongshan Haiji for RMB 807.5 million. Upon completion of this transaction, Zhongshan Haiji will become a wholly-owned subsidiary of the company. Zhongshan Weiming Haiji Biopharmaceutical Co., Ltd., established in 2004, is located in the National Health Base of the Torch Development Zone in Zhongshan City. It is a gene-engineering biopharmaceutical enterprise with independent intellectual property rights. Business scope: Research, production, and sales of genetically recombinant products (injectable recombinant human growth hormone, rhGH), as well as research on biological products.

Medtronic Harmony TPVR System Receives CE Approval

Recently, Medtronic's self-expanding Harmony Transcatheter Pulmonary Valve Replacement (TPVR) system has received CE Mark approval, meaning the device can now be sold and marketed throughout the European Union. The Harmony TPVR system was previously approved by the U.S. Food and Drug Administration (FDA) in 2021 for treating severe pulmonary regurgitation (PR) in pediatric and adult patients with native or surgically repaired right ventricular outflow tracts (RVOT). Due to durability issues, Medtronic did initiate a voluntary recall in 2022 but reintroduced the device less than a year later.

AI Machine Implant System Applied in Cochlear Implant Surgery

Recently, ENT experts from across China gathered at the Boao Super Hospital in Hainan to witness and participate in several milestone SYNCHRONY 2 cochlear implant surgeries. These surgeries have drawn significant attention due to the use of an artificial intelligence robotic implantation system. The successful application of this innovative technology not only marks a new era of minimally invasive cochlear implant surgery but also once again places Boao Super Hospital at the forefront of global medical innovation. During the surgeries, the AI robotic implantation system demonstrated its unique advantages. Composed of a robotic arm (OTOARM) and a robotic hand (OTODRIVE), the system is lightweight, portable, and capable of precisely mapping the surgical path while steadily inserting the cochlear implant electrode at an extremely low speed (as slow as 0.1 mm/s). This slow and steady insertion, combined with the soft electrode design of SYNCHRONY 2, effectively preserves the delicate structures of the cochlea and retains the patient's residual hearing.

AK+ Guard™ Hyperkalemia Detection Software Receives FDA Breakthrough Device Designation

Recently, AccuCardia announced that its ECG-based artificial intelligence software, AK+Guard™ for hyperkalemia detection, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This research technology uses lead I ECG data to alert patients and clinicians about moderate to severe hyperkalemia (excessive potassium in the blood), which can lead to cardiac arrest. AK+Guard is designed to work with various FDA-approved consumer and clinical wearable devices that currently capture lead I ECG data (such as smartwatches), enabling hyperkalemia monitoring outside of clinics and facilitating early intervention for high-risk populations. These include patients with end-stage renal disease, chronic kidney disease (CKD), and other risk factors.

Number of Medical Device Products in China Reaches 307,221 in 2024

Recently, according to statistics from the data center of the High-End Medical Device Research Institute, as of December 2024, the total number of valid registrations and filings for medical device products in China reached 307,221, representing a year-on-year increase of 4.29%. Among these, imported products accounted for 28,130, while domestically produced products totaled 279,091, making up 90.84% of the total, with a year-on-year growth of 4.69%. In terms of product management categories, there were 169,633 Class I products, accounting for 55.22%, with a year-on-year increase of 3.56%; 113,201 Class II products, accounting for 36.85%, with a year-on-year increase of 4.44%; and 24,387 Class III products, accounting for 7.94%, with a year-on-year increase of 8.88%. In the breakdown by specific fields, in vitro diagnostic reagents, as well as infusion, nursing, and protective devices remain the primary areas for newly registered products.

Innodem Magnesium Alloy Bone Screw ObtainsFDA Breakthrough Device Designation

Recently, the controllable degradable magnesium alloy bone screw developed by Suzhou Innova Medical Technology Co., Ltd. has been awarded the Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). As a company in China with authoritative certification for absorbable orthopedic implant technology, Innova fills the gap in this technology in the Chinese market and overcomes the limitations of international similar products in terms of indications. This designation not only marks that magnesium alloy orthopedic implant technology in China has reached international leadership but also provides new treatment options for patients worldwide with unmet orthopedic needs. The FDA's Breakthrough Device program offers an expedited review pathway specifically for medical devices with high clinical demand and disruptive technology to address unmet medical needs. This designation imposes extremely strict requirements on product technology and clinical validation, and very few domestically produced devices have been approved.

Douyin Doubles Down on Healthcare

Recently, Beijing ByteDance Network Technology Co., Ltd., a wholly-owned subsidiary of TikTok Group (Hong Kong) Limited, invested 734 million RMB to establish "Beijing Ninghe Kangrui Medical Management Co., Ltd.," with business scope including "hospital management; technical services, technical development, technical consulting," among others. On the other hand, market rumors suggest that the TikTok platform plans to conditionally open up to the entire pharmacy industry. The specific conditions include: only chain pharmacies can be onboarded, with a registration time of over one year and a deposit of 200,000 RMB (for pharmacy product categories); additionally, merchants must possess a Class II medical device operation filing certificate, medical device advertisement review form and sample, pharmaceutical operation license, and at least one licensed pharmacist registration certificate.

GE Healthcare's Innovative Angiography System Approved by NMPA

Recently, GE Healthcare announced new developments: its image-guided therapy angiography system, Allia IGS Pulse Arctic Heart, has successfully received approval from the National Medical Products Administration (NMPA). This milestone marks the system's upcoming application in China's medical market, providing healthcare professionals with a new tool for interventional treatments. The Allia IGS Pulse Arctic Heart showcases several innovative technological highlights. Its imaging chain features 10mhu characteristics, allowing medical professionals to obtain clearer imaging support for more accurate diagnosis and treatment planning. Additionally, the system introduces an enhanced surgical experience. During actual procedures, doctors benefit from the system's ease of use and precision, improving both surgical efficiency and safety.

Swiss Medtech CompanyCustomSurg Develops Preoperative Planning Software

Recently, CustomSurg, a Swiss medical technology company founded in 2021, is dedicated to developing preoperative planning software for creating personalized fixation surgery plans and 3D-printed implants for complex joint fractures. Relying on precise data support, the software assists doctors in selecting and implementing surgical plans, effectively shortening treatment time and improving the stability of fracture surgeries. CustomSurg has developed preoperative planning software specifically for complex joint fractures, which transforms current experience-based subjective clinical judgments into biomechanics-driven treatment solutions, helping doctors create fracture surgery plans more quickly and objectively, thus reducing treatment time. The software can also design and produce personalized 3D-printed implants based on specific case conditions, further enhancing surgical stability, and lowering treatment costs.

42 IVD Companies' Centralized Procurement Bids Below 10 Cents

Recently, the Jiangxi Provincial Medical Insurance Bureau officially announced the winning results of the inter-provincial alliance's centralized bulk procurement of biochemical test reagents such as sugar metabolism. A total of 2,314 specifications from 154 companies were selected, with an average price reduction of 70%. In the biochemical reagent procurement led by Jiangxi, 42 companies quoted prices below 0.1 yuan for ion trace elements and sugar metabolism products. These companies include listed or well-known firms such as Autobio, Nine Strong Bio, Leadman, Maccura, New Industries Biomedical, Mindray Medical, Roche Diagnostics, and Beckman Coulter. The "Ion Trace Elements | Calcium (CA)" products from Roche Diagnostics, Beckman Coulter, Siemens Healthineers, Mindray Medical, and New Industries Biomedical were all selected at a price of 0.07 yuan per test. Similarly, New Industries Biomedical’s "Sugar Metabolism | Glucose (GLU)" product was also selected at 0.07 yuan, while Roche Diagnostics' "Ion Trace Elements | Phosphorus (P)" was selected at 0.06 yuan.

Chongqing Releases the "Chongqing Intelligent Medical Equipment Industry Innovation and Development Action Plan (2025-2027)

On January 9, Chongqing released the Intelligent Medical Equipment Industry Innovation and Development Plan, aiming to promote high-quality growth in the industry. Focusing on advanced medical devices and other fields, the plan fosters collaborative innovation between industry, academia, research, and medicine. It seeks to build an incubation system for the industry, encourage scientific researchers to pursue innovation and entrepreneurship, and drive the integration of medical and engineering innovations.

The General Office of the State Council Releases the "Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry"

Recently, the General Office of the State Council released the "Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry," furthering the reform of drug and medical device regulation. It fully supports major innovations, expedites the approval and market entry of clinically urgent drugs and high-end medical equipment, and drives the high-quality development of the pharmaceutical industry.

Shanghai Implements Temporary Reduction in Registration Fees for Class II Medical Devices Produced in China

Recently, the Shanghai Municipal Development and Reform Commission and the Shanghai Municipal Finance Bureau issued a notice to temporarily reduce the registration fees for domestically produced drugs and Class II domestic medical devices. The implementation period will be from January 1, 2025, to December 31, 2025. The notice stated that the registration fees for domestically produced drugs (including supplementary application registration fees and re-registration fees) collected by the municipal drug supervision and administration system will be temporarily reduced to 50% of the current standard. The registration fees for Class II domestic medical device products (including initial registration fees, change registration fees, and renewal registration fees) will be temporarily reduced to 35% of the current standard. Other regulations, such as the scope of chargeable items, remain unchanged.

Guizhou Adjusts Registration Fee Standards for Pharmaceuticals and Medical Device Products

Recently, it was learned from the Guizhou Provincial Development and Reform Commission that Guizhou Province has decided to adjust the registration fee standards for drugs and medical device products starting from January 1, 2025. The notice specifies that the supplementary application registration fee for drugs will be canceled, and the original supplementary application registration items will be changed to filing matters, with no further charges. The standard fee for accepting domestic Class II medical device product registration will be reduced by 50%, meaning: the initial registration fee will be reduced to 21,450 yuan, the change registration fee will be reduced to 8,800 yuan, and the renewal registration fee (once every five years) will be reduced to 8,800 yuan. When applying for a change or renewal registration of a medical device product, if the technical review of the medical device product does not involve on-site inspection as per relevant regulations, the change or renewal registration fee will be waived.

Fujian Free Trade Zone Landing "Green Medical Device Bonded Maintenance" Project

Recently, the "Green Bonded Medical Device Repair" project has been implemented in the Xiamen area of the Fujian Free Trade Zone. As a key "pilot" practice by the Fujian Free Trade Zone in the medical device sector, this green and sustainable development project, jointly developed by Belson Electronics (Xiamen) and GE Healthcare China, mainly focuses on reducing carbon emissions and resource waste during the medical device repair process. It integrates medical technology innovation with supply chain collaborative innovations, including spare parts repair and equipment repair, to promote the green and sustainable development of the medical device industry chain through practical actions. The Fujian High-Tech Free Trade Zone Management Committee, the Chinese Medical Equipment Association, the Medical Device Supply Chain Branch of the China Federation of Logistics and Purchasing, GE Healthcare China, and a cluster of suppliers including Belson Electronics (Xiamen), have jointly advocated for the creation of a "Green Supply Chain Innovation Ecosystem Alliance for Medical Devices."

Beijing Accelerates the Innovative Development of Brain-Computer Interfaces

Recently, the Beijing Municipal Science and Technology Commission, the Zhongguan Village Science Park Management Committee, and the Beijing Municipal Bureau of Economy and Information Technology issued the "Action Plan for Accelerating the Innovative Development of Brain-Computer Interface in Beijing (2025-2030)", requiring the promotion of breakthroughs across the entire chain of brain-computer interface technology innovation and industrial cultivation. The notice mentioned that by 2027, a number of major original achievements will be produced, breaking through key core technologies such as brain-computer interface electrodes, chips, and encoding-decoding algorithms. It aims to enhance the performance of products like miniaturized high-throughput implantable sensors, high-channel integrated implantable chips for acquisition and stimulation, and implantable micro-batteries to reach international standards, develop intelligent brain-computer systems, and achieve preliminary clinical applications. The plan also aims to cultivate 3-5 potential unicorn and unicorn companies with core competitiveness. It seeks to promote close alignment and deep integration between innovative sources and industrial applications, establish 2-3 product experience and exhibition centers with unique features, and accelerate the implementation of a series of new brain-computer interface technologies, products, and models across multiple scenarios.

Hangzhou Promotes High-Quality Economic Development

Recently, the Hangzhou Development and Reform Commission, in conjunction with relevant departments, has studied and drafted the "Several Policies on Promoting High-Quality Economic Development (2025) (Draft for Comments)", with the comment solicitation period from January 4, 2025, to January 14, 2025. Some of the policy contents are as follows: Deeply implement the "415X" advanced manufacturing cluster cultivation project, continuously build five major industrial ecosystem circles, and accelerate the construction of a modern industrial system with Hangzhou characteristics. Layout new quality productive industry tracks according to local conditions. Accelerate the construction of five major industrial ecosystem circles in intelligent IoT, biomedicine, high-end equipment, new materials, and green energy, focus on key细分tracks, and promote high-quality industrial development. Concentrate on laying out potential industry tracks at the风口, carefully plan the future industrial development path of Hangzhou, and vigorously develop five major风口potential industries: general artificial intelligence, low-altitude economy, humanoid robotics, brain-like intelligence, and synthetic biology.

New Edition"Guidelines for the Application of the 'Hong Kong-Macao Medicine and Device Access Program' Released"

Recently, according to the application and approval requirements for the import and use of urgently needed Hong Kong and Macao medicines and medical devices in mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area as stipulated in the "Regulations on the Administration of Importing Hong Kong and Macao Medicines and Medical Devices in the Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area of Guangdong Province," the Guangdong Provincial Drug Administration and the Guangdong Provincial Health Commission have decided to issue the "Guidelines for the Application for Importing Hong Kong and Macao Medicines and Medical Devices in the Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area." In light of current work practices, the original "Interim Provisions on the Administration of Urgently Needed Imported Hong Kong and Macao Medicines and Medical Devices for Clinical Use in the Mainland of the Guangdong-Hong Kong-Macao Greater Bay Area" (Yue Drug Supervision Regulation Xu [2021] No. 4), the "Guidelines for Designated Medical Institutions in the Mainland of the Guangdong-Hong Kong-Macao Greater Bay Area to Import and Use Hong Kong and Macao Medicines and Medical Devices," and the "Guidelines for Non-First-Time Use of Urgently Needed Imported Hong Kong and Macao Medicines and Medical Devices by Designated Medical Institutions in the Mainland of the Guangdong-Hong Kong-Macao Greater Bay Area" (Yue Drug Supervision Bureau Xu [2022] No. 47) will be abolished as of the date of this announcement.

Note: The information in this article is compiled based on online news reports.

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