Search Results for “medical device” – Page 39 – media

【EXPERT Q&A】What are the general procedures for CE certification?

Drugdu.com expert’s response: The process for obtaining CE certification generally includes the following steps: Ⅰ. Preliminary Preparations Determine Product Category and Directive: Firstly, it is necessary to determine the product category and the applicable CE directive. Different categories of products may be subject to different directives and standards, such as the Low Voltage Directive (LVD), Machinery Directive (MD), Electromagnetic Compatibility Directive (EMC), etc. Prepare Technical Documentation: Based on the requirements of the applicable directive, prepare the necessary technical documentation. These documents should be detailed, accurate, and meet the requirements of the directive. Technical documentation typically includes product specifications, design drawings, user manuals, circuit diagrams, block diagrams and wiring diagrams, lists of key components or raw materials, etc. Ⅱ. Select Certification Body and Submit Application Select Certification Body: Choose a qualified and experienced certification body for CE certification assessment. The certification body will test and evaluate the technical documentation and samples ...
- Source: drugdu
- 66
- November 1, 2024
The hearing aid industry has a huge gap

In the current Chinese medical device industry, competition is extremely fierce, and many fields have become saturated, making it difficult to find new growth points or development space. But this set of data shows that there is a huge resource gap in the intervention of hearing loss in the elderly population in China. According to the “China Elderly Hearing Loss and Hearing Aid Application Survey” released by Tmall Health, Beijing Hearing Association, and Sonova Group, there is one professional hearing service provider for every 90000 people in China, which is much lower than the United States (9000:1). This huge gap not only reflects the scarcity of human resources allocation in this field in China, but also reflects the large scale of the population with hearing loss. 1. There are 120 million elderly people with hearing loss, and the wearing rate of hearing aids is less than 5% Hearing loss is ...
- Source: drugdu
- 58
- October 31, 2024
GE Healthcare, this product is being produced for the first time in the United States

Recently, GE Healthcare is manufacturing the integrated Omni Legend PET/CT at its new production facility in Wisconsin. This marks the first time that the system has been produced domestically in the United States. 01. Innovative product Omni Legend PET/CT GE HealthCare launched its first PET/CT: Omni Legend on the fully digital Omni platform at the European Association for Nuclear Medicine (EANM) annual meeting in October 2022. The system achieved significant improvements in sensitivity, efficiency, radiation dose, and patient comfort. The system is equipped with a new digital BGO (dBGO) detector, aimed at improving examination efficiency, enhancing patient experience, and boosting diagnostic confidence. The system adopts a new category of digital BGO (dBGO) detector materials, with small crystal size and sensitivity more than twice that of existing digital scanners, which can achieve faster total scanning time and impressive small lesion detectability It aims to improve operational efficiency, enhance patient experience, and ...
- Source: drugdu
- 66
- October 30, 2024
Endoscopic equipment company completes over 100 million yuan Series B financing

Recently, Shenzhen Xingchen Sea Medical Technology Co., Ltd. (hereinafter referred to as “Xingchen Sea Medical”) announced the completion of a Series B financing of over 100 million yuan, led by Yuansheng Venture Capital, with continued investment from old shareholders Junlian Capital and Daotong Investment, and Haoyue Capital serving as the exclusive financial advisor. It is reported that this round of financing will help Xingchen Hai Medical further expand its production capacity, accelerate new product research and development, and expand its global market, promoting its rapid development in the field of disposable endoscopes. Complete 4 rounds of financing Xingchen Sea Medical was established in October 2020, with a founding team from domestic and foreign head medical device companies. With over ten years of experience in minimally invasive surgical product research and development, global marketing, and production management, we are committed to becoming an innovative leader in endoscopic intervention diagnosis and treatment. ...
- Source: drugdu
- 64
- October 29, 2024
Significant Collaboration with Philips

On October 25, 2024, Medtronic and Philips announced the establishment of a strategic advocacy partnership centered on stroke care. The two companies will work together to raise awareness of the potential health and economic benefits that timely diagnosis and treatment of stroke can bring to patients, families, and society, and further expand and strengthen their partnership with the World Stroke Organization (WSO). It is reported that this cooperation has three key focus areas, including raising public awareness of stroke symptoms and the importance of timely medical treatment, improving treatment accessibility by increasing the number of hospitals with stroke treatment capabilities and providing training, and using advanced technology to create a comprehensive stroke care system to support early diagnosis, effective treatment, and postoperative monitoring. 01. Focus on stroke care, Philips and Medtronic reach cooperation It is reported that in this collaboration, Medtronic and Philips will work together to promote awareness of ...
- Source: drugdu
- 67
- October 29, 2024
Medtronic and Philips reach major cooperation

On October 25, 2024, Medtronic and Philips announced the establishment of a strategic advocacy partnership centered on stroke care. The two companies will work together to raise awareness of the potential health and economic benefits that timely diagnosis and treatment of stroke can bring to patients, families and society, and further expand and strengthen their partnership with the World Stroke Organization. It is reported that this cooperation has three key focus areas, including raising public awareness of stroke symptoms and the importance of timely medical treatment, improving treatment accessibility by increasing the number of hospitals with stroke treatment capabilities and providing training, and using advanced technology to create a comprehensive stroke care system to support early diagnosis, effective treatment and postoperative monitoring. Philips and Medtronic reach cooperation It is reported that in this cooperation, Medtronic and Philips will work together to advocate for raising awareness of the potential health and ...
- Source: drugdu
- 48
- October 29, 2024
【EXPERT Q&A】Do I need a registered clinical trial for 3D endoscopy?

Drugdu.com expert’s response: Three-dimensional endoscopes typically require registration clinical trials, but the specifics of whether they are conducted and the requirements for clinical trials may vary based on product characteristics, registration region, and regulatory requirements. Ⅰ. Clinical Trial Requirements for Three-dimensional Endoscopes Regulatory Requirements: According to the relevant regulations of the National Medical Products Administration, medical devices generally need to provide clinical trial data during registration to prove their safety and effectiveness. As a type of medical device, three-dimensional endoscopes have certain complexity and risk in their design and use, thus usually requiring clinical trials to assess their performance. Product Characteristics: Three-dimensional endoscopes feature three-dimensional imaging capabilities, providing a more three-dimensional surgical view and aiding doctors in making more accurate judgments and operations. However, this new technology may also bring some unknown risks and side effects, which need to be discovered and assessed through clinical trials. Registration Region Differences: Different countries and regions may ...
- Source: drugdu
- 67
- October 28, 2024
Hengrui Medicine Reports Revenue and Net Profit Growth in Q3

On the evening of October 24, Hengrui Medicine announced its Q3 performance report for 2024, showcasing steady growth in performance. For the first three quarters of 2024, Hengrui reported an operating revenue of 20.189 billion yuan, marking an increase of 18.67% year-on-year. The net profit attributable to shareholders reached 4.620 billion yuan, an increase of 32.98%, while the net profit after deducting non-recurring gains and losses was 4.616 billion yuan, reflecting a 37.38% increase, demonstrating robust development momentum. According to the report, Hengrui’s R&D expenditures reached 4.549 billion yuan in the first three quarters of 2024, marking a significant increase of 22% year-on-year. This ongoing high-intensity investment in R&D is providing strong momentum for the transformation of the company’s innovative achievements. As a result of these sustained investments, Hengrui is seeing a continual emergence of innovative outcomes. During the reporting period, Hengrui launched its self-developed Class 1 new drug, Fuhuanqi ...
- Source: drugdu
- 85
- October 28, 2024
1.774 billion, Mindray has big moves

Recently, the “Maidong Technology Park”, which is the global headquarters base of Mindray Animal Medical, officially started construction in Longhua, Shenzhen. It is reported that the land for the Maidong Technology Park project will be sold in September 2023, covering an area of 58600 square meters and a building area of 176000 square meters. The total planned investment is 1.774 billion yuan. After completion, it will create an intelligent manufacturing “black light” factory with high-precision automation equipment covering the entire area. Through automatic and intelligent on-site logistics scheduling, efficient, high-quality, and low-cost manufacturing will be achieved. 01. Expected annual output value exceeds 12 billion In recent years, Mindray Medical has begun to focus on four emerging businesses, namely animal medicine, minimally invasive surgery, orthopedics, and AED, on the basis of its traditional three core businesses. In 2022, Li Xiting, Chairman of Mindray Medical, made a statement Animal medicine is a ...
- Source: drugdu
- 59
- October 26, 2024
Fosun Pharma’s Global Innovation Journey

From November 5 to 10, 2024, the 7th China International Import Expo (hereinafter referred to as “CIIE”) will be held in Shanghai. This year marks the 30th anniversary of the founding of Fosun Pharma. As a “full-time student” of the 7th CIIE, Fosun Pharma will continue to work with global partners in the Medical Devices and Healthcare Exhibition Area of Hall 7.1 (Booth No.: 7.1B3-02) to demonstrate its strong strength and far-reaching influence in becoming a global leading medical innovation integrator. Wu Yifang, Chairman of Fosun Pharma, said: “Over the past 30 years, Fosun Pharma has always insisted on innovation-driven development, actively embraced globalization, and deepened international cooperation. We are in sync with the development of the pharmaceutical industry and have demonstrated our innovative achievements and global strategic layout through the CIIE, an important platform for open cooperation. We will continue to promote global operations, accelerate the transformation of source ...
- Source: drugdu
- 65
- October 26, 2024

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