Search Results for “medical device” – Page 3 – media

Five innovative medical devices enter special review process

Recently, the Equipment Review Center of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 8 of 2024), intending to approve 5 innovative medical device projects to enter the special review process. 1. Human homologous recombination repair defect detection kit (high-throughput sequencing method): Xiamen Aide Biomedical Technology Co., Ltd Xiamen Aide Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as Aide Biotechnology) was established in 2008. It has long been deeply involved in the field of tumor gene testing, focusing on tumor drug co diagnosis. Relying on powerful bioinformatics algorithms, it has laid out detection reagents, software, and supporting instruments for various technology platforms, and provides detection services and drug clinical research services. In terms of products, Eide Biological Products has a wide range of products, which can detect the mutations of EGFR, KRAS, BRAF and other common genes, covering the disease ...
- Source: drugdu
- 78
- September 20, 2024
Global medical device giant Jiadeno shuts down factories and lays off employees

Recently, according to The Irish Times, global medical device giant Gardiner has convened a meeting with all employees of its Tullamore factory in Ireland to announce its decision to close the Tullamore factory and cease production of a product. With the closure of the factory, 315 job positions will be cut, and up to 300 employees will face layoffs. According to public information, the Tullamore factory has a total of 315 employees. The first batch of employees will resign in March and April 2025, and the second batch of employees will resign in April and May 2026. Purchased for 43.4 billion yuan, net profit increased fivefold, still facing closure The Tullamore factory was established in 1982 and has undergone several rotations over the decades. Originally established by American disposable medical product manufacturer Sherwood Medical, the Tullamore factory was acquired by Tyco Healthcare in 1998, which is now the predecessor of ...
- Source: drugdu
- 64
- September 19, 2024
Two innovative medical devices from Medtronic have been approved for market in China

Recently, the National Medical Products Administration announced the approval of Medtronic’s registration applications for two innovative products, the “Heart Pulse Electric Field Ablation Generator” and the “Disposable Heart Pulse Electric Field Ablation Catheter”. Unique advantages, suitable for two indications It is reported that the two innovative products approved this time are Medtronic’s PFA product – PulseSelect, which is the first PFA product approved by NMPA that can be used for both paroxysmal and persistent atrial fibrillation. PulseSelect is a new technique for treating atrial fibrillation (AF) using pulsed electric fields, which can provide bipolar and biphasic pulsed electric fields through a circular multi electrode array catheter. This technology consists of five parts: a controllable multi electrode annular ablation catheter, a PFA host ECG-Gated、 Tableside control、10Fr bidirectional sheath. It is worth mentioning that PulseSelect’s controllable multi electrode annular ablation catheter features a proprietary biphasic waveform, unique built-in guide wire, and a ...
- Source: drugdu
- 99
- September 13, 2024
【EXPERT Q&A】What certification is required for medical device export clearance to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States for customs clearance involves fulfilling a series of certifications and requirements, primarily encompassing the following aspects: Ⅰ. FDA Registration and Certification FDA Registration: Manufacturers or exporters need to register with the Food and Drug Administration (FDA) in the United States to legally sell medical devices in the American market. This process is typically completed through FDA’s Electronic Registration System (FURLS). 510(k) Premarket Notification: For medical devices classified as “Class II” (Premarket Notification), a 510(k) submission is generally required. This application demonstrates that the device is technologically similar to a legally marketed device and meets FDA requirements. The review period typically takes 90 days. PMA Application: For high-risk medical devices classified as “Class III” (Premarket Approval), a PMA (Premarket Approval Application) may be necessary. This is a more rigorous application requiring substantial clinical data and evidence to prove the safety and ...
- Source: drugdu
- 67
- September 13, 2024
Ten measures are favorable for innovative medical devices

Recently, the Guangzhou Municipal Health Commission of Guangdong Province issued the “Ten Measures of the Guangzhou Municipal Health Commission to Support the High-quality Development of Innovative Drugs and Devices”, covering the entire process of product research and development-hospital use-payment expansion. The notice proposes to urge medical institutions to hold at least one working meeting of the medical device-related committee every quarter, and hold a meeting within one month after the publication of the “Guangzhou Innovative Drug and Device Product Catalog”, and promptly include innovative drugs and devices in the medical institution’s drug or device catalog as needed, so as to achieve “all-out allocation” and give priority to selection. Encourage qualified medical institutions to accelerate the application of innovative medical devices such as active surgical instruments, passive implantable devices, medical software, medical imaging, radiotherapy, surgical robots, etc., and orderly promote the iterative upgrade of medical institutions’ equipment and facilities. ...
- Source: https://mp.weixin.qq.com/
- 51
- September 12, 2024
【EXPERT Q&A】Why domestic medical device bidding needs CE certification?

Drugdu.com expert’s response: The reasons for requiring CE certification in domestic medical device tenders can be elaborated from multiple perspectives: Ⅰ. International Recognition and Market Access of CE Certification International Recognition: CE certification is a prerequisite for market access in Europe. Medical devices with CE certification must comply with European standards such as EN60601 and EN45545. This signifies that CE certification not only enjoys a high level of recognition in the European market but is also globally recognized as an important indicator of product quality and safety. Market Access: For medical device manufacturers aiming to enter the European market, CE certification is indispensable. Without the CE mark, it is illegal to sell or distribute medical devices within the European Economic Area. Therefore, requiring CE certification for domestic medical devices in tenders helps enhance their competitiveness in international markets. Ⅱ. Enhancing Product Quality and Safety Quality Improvement: To obtain CE certification, ...
- Source: drugdu
- 63
- September 9, 2024
Two innovative medical devices have been approved for market launch

On September 3rd, the National Medical Products Administration announced that it has recently approved the registration applications for two innovative products, the “Navigation Positioning Microwave Ablation System” of True Health (Zhuhai) Medical Technology Co., Ltd. (hereinafter referred to as “True Health Medical”) and the “Hepatitis B Virus Surface Antigen (HBsAg) Detection Kit (Chemiluminescence Method)” of Fuji Ruibiou Co., Ltd. (hereinafter referred to as “Fuji Ruibiou”). True Health Medical: International First Product Founded in 2018, True Health Medical is a national high-tech enterprise specializing in the research and production services of surgical robots. Based on artificial intelligence technology, it integrates intelligent robot systems into the diagnosis and treatment process through the close integration of industry, academia, research, and medicine, achieving a comprehensive medical technology system with precise puncture of soft tissue lesions throughout the body as a diagnostic and treatment method. Precise puncture is a means to deliver minimally invasive treatment ...
- Source: drugdu
- 87
- September 6, 2024
Tiktok is so convenient for selling medicines and medical devices

Tiktok is so convenient for selling medicines and medical devices! Tiktok, as the world’s leading short video platform, has a huge user base covering all age groups and interest areas. This provides a huge potential market for pharmaceutical companies, which can directly reach a large number of target consumers. The platform supports direct links to e-commerce platforms or corporate official websites to facilitate users to purchase. Pharmaceutical and medical device companies can embed purchase links in videos or guide users to follow stores to promote sales conversion. At the same time, through Tiktok’s live broadcast function, companies can also display products, answer user questions, etc., to further promote sales. It’s so convenient! How to do Tiktok well? Pharmaceutical and medical device companies need to make efforts in many aspects such as clear goals, precise positioning, high-quality content, effective conversion and compliant operations to do marketing on Tiktok. Only through continuous optimization ...
- Source: drugdu
- 69
- September 2, 2024
【EXPERT Q&A】What are the advantages of MDSAP medical device system certificate?

Drugdu.com expert’s response: The MDSAP (Medical Device Single Audit Program), also known as the “Medical Device Single Audit Program,” is an audit process recognized and joined by five medical device regulatory agencies from the United States FDA, Australia TGA, Brazil ANVISA, Canada HC, and Japan MHLW. This system certification brings numerous benefits and advantages to medical device manufacturers, primarily in the following aspects: I. Streamlining the Audit Process Reducing Redundant Audits: MDSAP employs a one-time audit process that encompasses the regulatory requirements of multiple countries. Manufacturers need to undergo a single audit to meet market access requirements across participating nations, eliminating the duplication of effort and time waste associated with multiple audits. Unifying Audit Standards: MDSAP certification ensures that a manufacturer’s quality management system and products align with the audit standards and requirements of the five participating countries and regions, facilitating consistency in quality and compliance and simplifying audit procedures ...
- Source: drugdu
- 68
- August 28, 2024
【EXPERT Q&A】What is a passive medical device?

Drugdu.com expert’s response: Passive medical devices refer to those that do not rely on external energy sources (such as electricity or batteries) to perform their intended functions. These devices typically utilize physical principles like mechanics, optics, acoustics, and thermodynamics to achieve their functions, with their energy primarily derived from the human body itself or gravitational forces. I. Characteristics of Passive Medical Devices Energy Source: Passive medical devices do not depend on external power sources or other forms of energy. Instead, they operate directly using natural forces such as the human body or gravity. Function Realization: They achieve their intended medical functions through physical principles like mechanical force, pressure, optical properties, etc. Safety: Since they do not rely on external power, these devices generally do not generate electromagnetic interference or radiation during use, making them safer for the human body. II. Classification of Passive Medical Devices Passive medical devices can be ...
- Source: drugdu
- 71
- August 26, 2024

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