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    Home > Medical News > Latest Medical News > A batch of medical devices named by the State Drug Administration (attached list)

    A batch of medical devices named by the State Drug Administration (attached list)

    • Last Update: 2021-02-24
    • Source: Internet
    • Author: User
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    Pharmaceutical Network February 20, these medical devices, the first in China on February 18, according to the Official Website of the State Council, the State Drug Administration issued the "2020 Medical Device Registration Report."
    the above-mentioned work report shows that in 2020, the State Drug Administration approved a total of 26 innovative medical device products on the market.
    These innovative product core technologies have China's invention patent rights or invention patent applications have been disclosed by the patent administrative department of the State Council, the main working principle / mechanism of action of the product for the domestic initiative, with significant clinical application value.
    from 2014 to 2020, the State Drug Administration approved 99 innovative medical devices, of which 78 enterprises in 14 provinces and 4 enterprises in 2 countries were involved in the import of innovative medical devices.
    Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang have the largest number of approved products and corresponding enterprises, accounting for about 81% of the 99 approved innovative medical devices.
    January 13 this year, according to the State Drug Administration, approved the registration application for the innovative product "Atheral Fork Stent System" produced by Xianjian Technology (Shenzhen) Co., Ltd. for the treatment of abdominal aneurysms or total aneurysms.
    this is China's independent research and development of the first reconstruction of the artery medical devices, but also China's 100th approved for the market of innovative medical devices.
    According to China Food and Drug Network combing, 96 of the 100 products, involving 14 provinces, autonomous regions and municipalities directly under the Central Government of 78 medical device enterprises, accounting for 96% of all products, 4 imported products, involving 4 enterprises in two countries.
    the location of approved products, the number of innovative medical devices in industrial provinces ranked highest, respectively, 25 in Beijing, 19 in Shanghai, 17 in Guangdong and 14 in Jiangsu.
    from the product characteristics, 43 active devices, 37 passive devices, in-body diagnostic reagents and equipment 20.
    it is understood that on February 7, 2014, the former State Food and Drug Administration issued the Special Approval Procedure for Innovative Medical Devices (Trial), which took effect on March 1, 2014, thus beginning the vigorous development of innovative medical devices in China.
    By November 2018, the State Drug Administration revised and issued the Special Review Procedure for Innovative Medical Devices, which improves the application situation, refines the application process, enhances the effectiveness of the innovation review, improves the review method and notification form, and clearly prioritizes changes in licensing matters for innovative medical devices.
    25 medical devices, named by the State Drug Administration according to the above-mentioned work report, the State Drug Administration on the representative of innovative medical device products, as follows: (1) puncture surgery navigation equipment: the product by the host, electromagnetic generator, navigation software composition, with specific electromagnetic tools supporting the use of adult lung and abdominal solid organ puncture surgery navigation.
    This product is the first puncture surgery navigation device for adult lung and abdominal soft tissue solid organs, compared with the conventional CT guidance method, can improve puncture accuracy, reduce the number of injections and CT scans, has significant clinical application value.
    the product preoperatively based on patient CT data to develop a navigation plan, the use of electromagnetic positioning principle for surgical navigation, has been 10 Chinese and U.S. invention patents granted.
    (ii) Coronary Blood Flow Reserve Score Calculation Software: The product is based on coronary artery CT vascular image, consisting of an installation disc and an encryption lock, and the functional module includes the basic operation of the image, vascular segmentation and reconstruction based on deep learning technology, vascular centerline extraction, and blood flow reserve score calculation based on deep learning technology.
    has obtained one invention patent and two invention patents are in the substantive examination stage.
    the product adopts noninvasional technology, can reduce unnecessary coronary formation, avoid unnecessary intervention surgery, can reduce costs, relieve patient pain, and can be used for early diagnosis, with significant economic and social benefits.
    has not yet registered the same variety of products on the market, the international only one of the same varieties of products listed in the United States.
    products and domestic and foreign products of the same variety, performance indicators in the international leading level.
    (III) Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing): This product is used to qualitatively detect EGFR/KRAS/BRAF/HER2/ALK/ROS1 gene mutations in patients with non-small cell lung cancer (NSCLC) in tissue samples fixed by Folmarin.
    Among them, EGFR gene 19 exon loss and L858R point mutation were used for the accompanying diagnostic testing of gifentinib tablets and hydrochloric acid eclatinib tablets;
    based on a common PCR platform, the product combines specific modified quotations with RingCap ring-to-link amplification techniques to detect mutant genes contained in DNA/RNA samples.
    PCR amplification of target sequences by special modification quotations, at the same time, the end modification of amplification products using RingCap ring-mediated connection amplification technology, connecting specific sequence ends, combined with special PCR reaction procedures and the use of RingCap enzyme, on the ordinary PCR platform to achieve the sample DNA/RNA target sequence for high-volume sequencing use of the library construction, in order to achieve the accurate detection of multi-gene multi-target mutations.
    (IV) Pre-implantation chromosome non-whole times physical examination kit (semiconductor sequencing method): The product establishes a pre-implantation chromosomal abnormality detection method using embryonic blastocyst cells, using single-cell amplification technology, improves the ratio, erration and coverage of sequencing results;
    (v) Bio-absorbable coronary repamycin equip stent system: the product is composed of stent and delivery system, stent by stent substation, development marker, drug carrier coating three parts.
    is used to treat in-vascular stenosis in patients with primary coronary atherosclerosis, improve the patient's coronary artery blood flow and prevent the occurrence of re-stenosis, reference blood vessel diameter 2.75mm-3.75mm, lesions length ≤24mm.
    Compared with traditional metal drug stents, the product is expected to have the following advantages: 1. The final degradation product of the stent is water and carbon dioxide, reducing late-stage thrombosis;
    (vi) Drug balloon expansion catheter: The product is OTW-type balloon expansion catheter, consisting of balloon, development ring, inner tube, outer tube, stress diffusion tube and Y-type connector.
    is used for balloon dilation of the jointarteries (except sub-knee arteries) during endovascular angioformation in the peritanetic cavity to treat atherosclerotic stenosis or ocular lesions.
    The product in clinical applications through dilated unitsarteries (except sub-knee arteries), the drug coating fully and the lesions of the blood vessels end wall, the drug can be effectively released, thereby inhibiting the lesions of blood vessels again narrow, to achieve therapeutic purposes.
    long-term survival without implants, providing new options for clinical use.
    (vii) Cardiovascular optically relevant fault imaging equipment and accessories: The product consists of a host and disposable vascular imaging catheter, expected to be used for coronary artery imaging, for clinical patients who need intra-cavity interventional treatment, especially in stent implantation.
    The core technology of this product involves two invention patents, "Integrated Ultra-Micro Optical Co-relevant Fault Imaging Probe" and "A Cardiovascular 3D Optical Co-imaging System", which integrates optical interference, data acquisition, signal processing, GPU, PIU control, image processing and analysis modules, combining optical co-imaging technology with laser scanning cofocus technology to obtain two- and three-dimensional images of the tissue.
    the current market of only one domestic product and one imported product, the product is expected to reduce the price of equipment and its ancillary supplies, conducive to clinical application and promotion, so that more patients benefit.
    (viii) RNF180/Septin9 gene methylation test kit (PCR fluorescence probe method): This product is based on pcR fluorescent probe detection principle, for in-body qualitative detection of methylated RNF180 and Septin9 genes in human plasma, is the first to detect RNF180 and Septin9 gene methylation by fluorescent quantitative PCR method, an innovative tumor standard gastric diagnostic products.
    this product is intended for patients who have under been diagnosed by a clinician and who have refused to have a gastroscopy for personal reasons.
    product is not intended for tumor screening in the general population.
    based on existing research, it is limited to people with a family history of stomach cancer or at high risk of stomach cancer over 40 years of age, and the final diagnosis should be based on gastroscopic results.
    (9) plasma surgery equipment: the product consists of a host, disposable plasma surgery electrodes, power cords, iso-power cables, etc.
    expected to be used in medical facilities for cutting and clotting human tissue during open surgery.
    compared with conventional high-frequency surgical equipment, the product has less damage and better postoperative healing conditions, and can be used for minimally invasive and delicate surgical operations such as skin and shallow tissue.
    can further reduce the cost of treatment and reduce the financial burden on patients.
    (10) Tumor Electric Field Therapy Instrument: The product consists of an electric field generator, an electric field patch, a power adapter, a battery, a battery charger, a connecting cable box and an optional accessory.
    is suitable for relapsed on-screen glioblastoma and newly diagnosed on-screen glioblastoma diagnosed by histopathology or imaging at the age of 22 and above.
    this product is the first medical device to use electric field to inhibit the principle of cell division, and to inhibit the filamentation process of tumor cells through the cross-change electric field, so as to achieve the inhibition effect of glioblastoma.
    has not yet approved similar products for listing in China.
    The product can be used as another treatment method for patients with glioblastoma after surgery and chemotherapy, the product is wearable, the use of non-invasive treatment of patients, clinical use risk is relatively low, for delaying tumor progression, prolonging patient survival, improve the quality of life has a certain effect.
    (11) catheter aortic valve system: The product includes a catheter aortic valve, a catheter aortic valve delivery system, catheter membrane kit, a catheterial balloon catheter, valve preset device.
    valve consists of bovine heart-wrapped flaps, cobalt chromium valve racks, and inside and outside the PET skirt.
    Is used to treat patients with high-risk or taboo surgery determined by the heart team, including cardiovascular surgeons (e.g., patients with severe calcification of the aortic valve stenosis with symptomatic calcification ≥8 percent or 30-day mortality ≥15 percent) according to the American Society of Thoracic Surgeons (STS) scoring system).
    This product uses balloon expansion technology, the valve frame provides high radial support, low valve frame height to adapt to the surrounding anatomical structure, and minimizes the risk of pacemaker implantation;
    the expected low rate of flap leakage in clinical applications.
    (12) by the catheter two-tip valve clip and maneuverable guide tube: the product consists of two parts: two-tip valve clip and transport catheter and maneuverable guide tube.
    , the two-tip valve clip and the conveyor tube consist of three main components: the conveyor catheter, the twistable sleeve and the two-tip valve clip.
    This product is suitable for patients with a high risk of two-tip valve surgery confirmed by the heart team in cases of significant symptomatic two-tip valve reflow (MR≥3 plus) caused by the sub-skin method to reduce the primary abnormality of the two-tip valve .degenerative two-tip valve reflow.
    the product can be used to reconstruct the two-tip valve through the lobe tissue butt to the perseward skin without opening the chest, in vitro circulation, and cardiac arrest.
    Optimize the existing treatment methods for secondary flap disease in China, and provide an alternative minimally invasivity treatment for patients with high-risk medium- and severe-tip valve reflow, improve their survival rate and improve the quality of life of patients, so as to better meet clinical needs.
    (13) Diabetic retinal lesions under the eye image auxiliary diagnostic software: the product consists of the installation of USB drive, functional modules include: diabetic retinal lesions auxiliary diagnosis cloud, doctor diagnosis client and system management side.
    is suitable for the analysis of colored eye images of adult diabetics to provide medical practitioners with auxiliary diagnostic recommendations on the visible retinal lesions of diabetes in stages II and above, as well as further medical examination.
    products are based on the reel neural network of the autonomous design network structure, based on the classification of the bottom image data, the algorithm model training and verification.
    By obtaining color photographs of patients' under-eye images taken by the under-eye camera, the images are calculated and analyzed using the above-mentioned deep learning algorithm, and the auxiliary diagnostic recommendations for diabetic retinal lesions are obtained and provided to qualified clinicians for reference.
    currently has no similar products approved for listing.
    (14) Diabetic retinal lesions under the eye image auxiliary diagnostic software: the product contains client-side software and server-side software, product server-side deployment in Alibaba Cloud, client-side deployment on client computers, server-side and client-side encrypted data interaction over the Internet.
    is suitable for the analysis of the image of the double-eye-free scattered colored eye base of adult diabetics, providing the practitioner with auxiliary diagnostic recommendations for the discovery of moderate non-proliferative (including) or above diabetic retinal lesions and further medical examination.
    products are based on the reel neural network of the autonomous design network structure, based on the classification of the bottom image data, the algorithm model training and verification.
    By obtaining color photographs of patients' under-eye images taken by the under-eye camera, the images are calculated and analyzed using the above-mentioned deep learning algorithm, and the auxiliary diagnostic recommendations for diabetic retinal lesions are obtained and provided to qualified clinicians for reference.
    currently has no similar products approved for listing.
    (15) hip coating ball head: hip coating ball head products consist of a metal ball head substrate and amorphoous carbon nano-multi-layer structure film, the film contains Ti
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