14 devices have entered the "Innovation Channel"!
Image source: CMDE官网 Translation: Image source: CMDE website
Fluorescence in situ hybridization (FISH) is an advanced techniqueNucleic acid molecular hybridization methodIt utilizes known fluorescently labeled single-stranded nucleic acids as probes, which, based on the principle of base complementarity, undergo processes such as denaturation, annealing, and renaturation to specifically bind to unknown single-stranded nucleic acids in the sample, forming detectable hybrid double-stranded nucleic acids.
The chromosome abnormality cell detection kit from Shengmei Biotech canLiquid biopsy technologyCapturing circulating abnormal cells from blood achieves over 90% sensitivity in early lung cancer screening, breaking the limitations of traditional biopsy.
In March 2016, Saint Medical was jointly invested and established by US Cynvenio Biosystems and Zhuhai Livzon Reagent Co., Ltd., a subsidiary of Livzon Pharmaceutical. After years of development, Saint Medical has mastered the world's advanced tumor liquid biopsy technology. Currently, Saint Medical owns two core technologies: LiquidBiopsy rare cell enrichment and separation, and MDA TEST for benign-malignant pulmonary nodule auxiliary diagnosis. LiquidBiopsy is a circulating tumor cell enrichment and separation platform that can directly connect to downstream molecular testing, while MDA TEST technology is a leading technology for early lung cancer screening using Circulating Abnormal Cells (CAC).
Biological hernia repair patches are medical materials made using biotechnology, primarily used for treating hernias. These biological hernia repair patches are mainly made from animal tissues (such as from pigs or cows) and undergo special treatments, such as decellularization and cryogenic freeze-drying techniques, to enhance their biocompatibility and applicability.
It is reported that this product is a naturally derived bio-regenerative material that can be completely degraded after implantation in the body. Its structural design is tailored to..."Submucosal layer + basement membrane" biomimetic structureThe material exhibits good histocompatibility, with interconnected pores throughout, facilitating the ingrowth of surrounding tissue cells and promoting the flow of tissue fluid.
Zhurong Medical was founded in 2016 and is an innovative high-tech R&D and production enterprise dedicated to surgical tissue reconstruction and regenerative medicine for tissue repair. It is worth noting that in 2021, Zhurong MedicalThe first in the countryThe innovative medical device Antisheng® biological hernia repair mesh based on "basement membrane biomaterials" has been approved for Class III certification and market launch.
Microsurgery Electrophysiology was established on August 31, 2010, and was listed on the Shanghai Stock Exchange's Star Market on August 31, 2022. It is a high-tech enterprise focused on the research, development, production, and sales of innovative medical devices in the field of electrophysiological interventional diagnosis and ablation therapy. The company comprehensively covers the product layout for cardiac electrophysiology procedures and is the first domestic manufacturer to provide a complete solution of three-dimensional cardiac electrophysiology equipment and consumables.Implemented the two mainstream ablation energy products of "radiofrequency + cryo".Collaborative layout.
It is reported that the intracardiac ultrasound catheter that entered the innovative channel this time is a disposable type.Equipped with three-dimensional ultrasound positioning functionWhen used in conjunction with ultrasound imaging equipment and the Columbus® three-dimensional cardiac electrophysiological mapping system during cardiac interventional procedures, it enables the acquisition of high-definition intracardiac structures and images of other instruments while simultaneously obtaining corresponding three-dimensional positions. This facilitates precise visualization of the procedure, assisting surgeons in more accurately assessing treatment outcomes and enhancing surgical safety.
According to the information retrieved from YaoZhi Patent Pass, MicroPort Electro-Physiology holds 221 authorized patents. Among them, a new patent was granted on March 21st of this year titled "Intracardiac Ultrasound Catheter and Intracardiac Ultrasound Imaging Device." This patent involves an intracardiac ultrasound catheter and intracardiac ultrasound imaging device.
Aikang Yicheng was established in 2003 and is a core subsidiary of Aikang Medical. Aikang Medical is one of the earliest companies globally to commercialize additive manufacturing technology (3D printing technology) and apply it to implants for joint replacement, spine, and trauma repair. The company possesses the 3D Printing Precise Construction Technology Platform, the Supravit Vacuum Plasma Spraying Technology Platform, the Navigation/Robotic Intelligent Technology Platform (VTS/IBot), and the Medical-Engineering Interactive Customization Platform (Innovative Custom Orthopedic Solution).
Currently, AK Medical is a leading enterprise in the field of artificial joints in China, ranking first in market share in China and among the top ten in the global hip joint market.
The magnetic-controlled non-invasive prosthesis system that entered the innovation channel this time, isUtilizing 3D printing technologyCustom bone scaffolds allow patients to adjust the length of the prosthesis without the need for a second surgery, bringing new hope for bone tumor treatment.
Shenqi Medical is an innovative medical device enterprise integrating R&D, production, and sales, with product portfolios covering cardiovascular intervention, structural heart disease, peripheral vascular intervention, and neurovascular intervention fields. Shenqi Medical also holds an affiliated company, HeartCare, which is China's first R&D and production enterprise for heart failure ultrafiltration treatment devices.
Currently, Shenqi Medical has 2 marketed products and 33 products in the pipeline, all of which are independently developed with comprehensive independent intellectual property rights. The anti-embolism cerebral protection device entering the innovation channel is used in neurointerventional surgery.Real-time interception of blood clots reduces the risk of stroke by 70%.
In addition, in March 2025, Shenqi Medical's independently developed QiChuan® SQ-Surgipath® transjugular intrahepatic puncture device was officially approved for market launch by the NMPA. This product is suitable for transjugular intrahepatic portosystemic shunt procedures to reduce portal vein pressure.
Mingche Biotechnology is a high-tech enterprise focusing on the research, development, production, and sales of ophthalmic medical devices, guided by technology development. Currently, Mingche Biotechnology has formed a multi-product line layout centered around minimally invasive glaucoma drainage tubes, along with sensor platforms, microneedle drug delivery platforms, and magnetic control surgical robot platforms for ophthalmic micro-devices.
The Gaira® glaucoma drainage tube entering the innovation channel this time is based on advanced structural design.实现了高效引流和防止低眼压的融合优势 Achieved the integrated advantages of efficient drainage and prevention of low intraocular pressure, and on this basisInnovatively developed light-curing hydrogel materials.It can effectively overcome the problems of traditional drainage tubes being prone to breakage and easy to fracture after long-term implantation.
Based on the concept of integrated diagnosis and treatment, a minimally invasive injectable intraocular pressure sensor has been developed, enabling 24/7 home-based real-time monitoring of intraocular pressure.The minimum detection accuracy can reach 0.1mmHg.
Fangke Biology was established in 2018 and joined Baiyang Pharmaceutical Group in 2020. It focuses on the innovative product transformation for major disease screening and is a high-tech enterprise that integrates high-throughput gene sequencing, immune microenvironment analysis, advanced biochemical detection of proteins, and clinical big data analysis technologies.
Leprosy is a chronic infectious disease caused by infection with *Mycobacterium leprae* (ML). The source of transmission is untreated leprosy patients, and the main routes of transmission include prolonged close skin contact and respiratory inhalation of droplets. Currently, leprosy is classified as a Category C legally notifiable infectious disease in China and has long been one of the major infectious diseases targeted for elimination by the national government.
The leprosy Mycobacterium nucleic acid detection kit developed by Fangke Biotechnology.Early detection and rapid diagnosis can be performed for this group of leprosy patients who have not yet developed disabilities or are suspected to have leprosy., enabling timely treatment and effectively preventing the spread of the disease and disability. The reagent kit is based on multiplex fluorescence PCR technology, selecting Folp1, RpoB, and GyrA genes of Mycobacterium leprae as amplification targets, designing specific primers and fluorescent probes for detecting Mycobacterium leprae DNA in samples, providing important guidance for the early diagnosis of leprosy.
Varian Medical Systems was founded in 1948 and is a global leader in providing diagnostic and treatment solutions for cancer and other major diseases. Since the 1990s, Varian Medical Systems has been involved in the development and research of proton therapy technology. In 2009, it officially entered the proton therapy system market comprehensively, quickly establishing a proton therapy business with advanced technology platforms such as superconducting cyclotrons and pencil beam scanning technology.In 2021, the company was acquired by Siemens Healthineers.
In November 2023, Varian Medical's proton therapy system was approved for market release by the NMPA. This product isFirst unitThe approved proton therapy system using superconducting cyclotron technology and 360-degree rotating gantry provides proton beams for radiotherapy, applicable for treating solid malignant tumors and certain benign diseases throughout the body. The system consists of an accelerator subsystem and a treatment subsystem.
Hantong Medical is an innovative medical technology enterprise focusing on interventional ultrasound technology. Its core technology is a fully self-developed ultrasound energy platform, and its first product is the renal artery ultrasound ablation system (uRDN), mainly used for the treatment of hypertension.
According to the different energy sources used for ablation, RDN pathways can be categorized into radiofrequency ablation, ultrasound ablation, cryoablation, and chemical (alcohol) ablation.Han Tong Medical has chosen a challenging path in the field of ultrasound ablation.
It is reported that the renal artery ultrasound ablation system (uRDN) independently developed by Hantong Medical optimizes the sound field output range, providing more stable ablation effects. It is also a product capable of performing 360° uniform energy field ablation in both the main renal artery and its branches. In addition, Hantong Medical is developing the next-generation ultrasound energy platform, which integrates ablation therapy with ultrasonic diagnosis, offering clinical advantages such as targeted ablation and real-time monitoring of ablation effects.
As the population ages, the prevalence of neurodegenerative diseases (such as Parkinson's disease, epilepsy, etc.) is increasing, driving up the demand for implantable neurostimulation systems.
An implantable neurostimulation system is aMedical devices that treat various diseases by electrically stimulating the nervous systemIt typically consists of electrodes, a pulse generator, and a battery, capable of regulating neural activity through precise electrical signals, thereby improving or restoring function. This device usually requires implantation into the patient's body during surgery, utilizing either implantable or non-invasive techniques. It works by stimulating, inhibiting, or modulating specific neurons and neural networks through electrical, chemical, optical, magnetic, or ultrasonic means, helping patients improve their quality of life or enhance bodily functions.
Neuracle Medical was founded on June 9, 2021. Its parent company, Neuracle Group, is one of the leading enterprises in China's brain science field. Its core products include video EEG machines, high-frequency high-channel EEG machines, brain function monitors, event-related potential devices, and transcranial electrical stimulation devices.
Coronary heart disease is a common cardiovascular disease worldwide, with a high incidence and mortality rate. With the aging population and changes in lifestyle, the number of patients with coronary heart disease continues to grow. However, traditional coronary intervention surgery requires doctors to manually operate instruments such as guidewires and catheters under X-ray fluoroscopy. The precision of manual operation is limited, making it difficult to manage complex lesions, resulting in longer surgery times and relatively higher risks of complications for patients.
With the increasing demand for treatment, the need for related equipment such as coronary intervention surgery control systems will continue to rise. Zhongke Hongtai's Coronary Intervention Surgery Control System will provide a new option for such patients.
Zhongke Hongtai was incubated and established by the Institute of Automation, Chinese Academy of Sciences, led by internationally renowned experts in the fields of medical robotics and artificial intelligence, including researcher Hou Zengguang from the Institute of Automation. It is worth mentioning that it has independently developed...The world's firstMulti-channel pan-vascular interventional surgical robot, compatible with mainstream interventional devices and complex interventional procedures, equipped with self-developed specialized consumables, dedicated to creating a comprehensive intelligent catheter lab solution for multiple departments, diverse procedures, and integrated diagnosis and treatment workflows.
JYBIO is a high-tech enterprise dedicated to the clinical testing and translational research of genetic diseases. Starting from the entire chain of "screening-diagnosis-translational research-treatment," JYBIO comprehensively addresses the challenges in the prevention, diagnosis, and treatment development of hereditary rare diseases.
Currently, Jiyi Biotech possesses a variety of technical platforms, including second-generation sequencing, peripheral blood chromosome karyotyping, flight nucleic acid mass spectrometry, tandem mass spectrometry/gas chromatography-mass spectrometry, and molecular platforms (MLPA/qPCR/first-generation sequencing), all of which contribute to the precise diagnosis of rare diseases. Additionally, it has two Nobel Prize-level technology platforms, iPSC and CRISPR/Cas9, combined with the NGS platform, enabling further functional studies on rare disease-related gene loci, rare disease drug screening, and new drug development.
The newborn TREC/KREC gene detection reagent kit that entered the innovation channel performed excellently in previous clinical trials. According to the data, when compared with foreign SCID screening data, the screening positivity rate of this reagent kit is at the median level among the reported large-scale screening study detection positivity rates, and actual data supports SCID screening. Beyond a single rare disease, can benefit other non-SCID children.
Kebang Gene is a company specializing in molecular diagnostic products for precision oncology, focusing on high-throughput gene expression profiling and AI big data analytics. It is dedicated to the research, development, production, and sales of molecular diagnostic products for precision oncology, and provides related scientific research and testing services.
Currently, it is deeply involved in tumor mRNA detection and artificial intelligence领域,with proprietary intellectual property rights for tumor marker products, and its core product isTumor Tissue Origin Gene Detection SystemIn addition, according to the patent map query on the pharmaceutical intelligence platform, KeyBang Gene currently owns 6 authorized patents, including methods and devices for pathological image analysis.
The colorectal cancer digital pathology image microsatellite instability analysis software developed by Kebang Gene, based on advanced and leading RNA molecular diagnostic technology, provides a new solution for precise tumor diagnosis. It uses digital image recognition for microsatellite instability, completes diagnosis in 10 minutes, and improves accuracy by 30% compared to manual analysis.
Biodegradable magnesium alloy materials exhibit extraordinary superiority in multiple dimensions such as degradability, mechanical properties, and biocompatibility compared to widely used biodegradable polymers like polylactic acid in clinical applications. Their emergence also ingeniously addresses long-standing challenges faced by traditional implants.
Huarong Sci-Tech's biodegradable magnesium alloy bone screws have shown, compared to traditional material screws,Significant advantages and clinical value:
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Completely biodegradable, no need for secondary surgery to remove it. -
The ingredients are safe and non-toxic, and can promote bone growth. -
To avoid stress shielding effect and facilitate bone tissue healing; -
The degradation curve is slow at first and then accelerates, which is consistent with the human skeletal growth cycle. -
Imaging examination can be visualized without interference from artifacts.
As the product progresses, it also symbolizes a significant breakthrough in China's degradable material technology, foreshadowing the broad prospects and infinite possibilities of degradable materials in medical applications.
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