Search Results for “medical device” – Page 2 – media

7 Innovative Medical Devices Enter Special Review Process

Recently, the National Medical Products Administration’s Device Review Center released the results of the special review application for innovative medical devices (No. 9 of 2024), intending to approve 7 innovative medical device projects to enter the special review process.1. Liver low-temperature perfusion system: Hangzhou Lepusheng Medical Technology Co., Ltd Hangzhou Lepusheng Medical Technology Co., Ltd. (hereinafter referred to as Lepusheng Medical) was founded in 2016, focusing on the independent research and development of advanced medical devices for the protection, preservation, repair, and transportation of transplanted organs. It is committed to becoming a domestic benchmark and a global leading solution provider in the field of organ perfusion preservation and resuscitation. Since its establishment, Lepusheng Medical has made breakthroughs in core technologies such as organ perfusion protection and transport repair, and is opening up a new model for organ protection in China. The research and development focus of Lepusheng Medical is on ...
- Source: drugdu
- 72
- October 23, 2024
【EXPERT Q&A】What is the process for medical device export?

Drugdu.com expert’s response: The process of exporting medical devices involves multiple steps, as detailed below: Ⅰ. Market Research and Preparation Target Market Research: Conduct in-depth research on the medical device demand, regulations, standards, and competitors in the target market. Understand factors that may affect transactions, such as the target market’s political stability, trade policies, and currency exchange rate fluctuations. Product Registration and Certification: Complete product registration and certification according to the regulatory requirements of the target market. For example, the European market requires CE certification, and the US market requires FDA registration. Ensure that the products comply with the regulations and standards of the destination country to avoid trade barriers and compliance risks. Establishing a Sales Network: Establish contact with distributors, agents, or medical institutions in the target market. Participate in international exhibitions, seminars, and other events to communicate face-to-face with potential customers and showcase product advantages. Ⅱ. Production and ...
- Source: drugdu
- 86
- October 21, 2024
Huawei enters the hot track of medical devices

Recently, the website of the State Intellectual Property Office updated a new invention patent, named “Method for controlling stimulator, stimulator, brain-computer interface system and chip”, and the inventor of the patent is Huawei Technologies Co., Ltd. It is reported that this is Huawei’s second brain-computer interface related patent. As early as June 2023, Huawei announced a patent called “A brain-computer interface device and information acquisition method”. Brain-computer interface is one of the most popular phenomenal technologies in recent years, and its potential in the medical field is highly expected by the industry. According to McKinsey’s calculations, the potential market size of global brain-computer interface medical applications is expected to reach US$40 billion in 2030, and it is expected to exceed the US$145 billion mark by 2040. With the increase in R&D investment, the medical application of brain-computer interface has gradually shifted from early abstract concepts to landing results. In September, ...
- Source: drugdu
- 72
- October 21, 2024
Suda Testing participates in the release of ESG standards for medical device companies, promoting sustainable development in the industry

On the morning of October 14, sponsored by the “the Belt and Road” Life Science and Technology Promotion Alliance, and jointly organized by the Shenzhen Life Science and Technology Industry University Research Capital Alliance, Suzhou Suda Health and Environmental Technology Research Institute Co., Ltd., Shenzhen Huada Intelligent Manufacturing Technology Co., Ltd., and Jiewen (Shenzhen) Technology Services Co., Ltd., the ESG standard seminar for the medical device industry was successfully held in Shenzhen. The purpose of this seminar is to jointly explore the current situation and challenges of ESG standards in the medical device industry, promote the formulation and implementation of standards, and enhance the industry’s international competitiveness and sustainable development capabilities. At the beginning of the meeting, relevant leaders from the Standards Department of Shenzhen Municipal Market Supervision Administration, Suzhou Medical Device Industry Development Group Co., Ltd., the “the Belt and Road” Life Technology Promotion Alliance, and Suzhou Suda Health ...
- Source: drugdu
- 74
- October 19, 2024
A medical device enters the innovation channel

Recently, the Shanghai Medical Products Administration announced that in accordance with the requirements of the “Special Review Procedure for Class II Innovative Medical Devices in Shanghai”, the Shanghai Medical Products Administration has organized relevant experts to review the special review application for Class II innovative medical devices in the city, and intends to agree to allow Shanghai Futuo Zhida Medical Technology Co., Ltd. (hereinafter referred to as “Futuo Zhida”) to enter the special review procedure for its disposable pulmonary nodule three-dimensional identification positioning marker. Developing innovative technologies with AR navigation systems Founded in 2018, Futo Zhida is a subsidiary of Fosun Pharma, focusing on innovative medical devices and surgical development. Its team has rich experience and a global perspective in the development of image navigation algorithms, intervention consumables design, and production. According to the Chinese Journal of Tuberculosis and Respiratory Sciences, the incidence rate and mortality of lung cancer rank ...
- Source: drugdu
- 63
- October 18, 2024
460 million! Migraine innovative medical device company completes Series B financing

Recently, ShiraTronics, an innovative medical device company for migraine, announced the completion of a $66 million (approximately RMB 460 million) Series B financing to support its innovative migraine treatment system. This round of financing was led by new investor Norwest Venture Partners, and other new investors included Seroba, OSF Ventures, Global BioAccess Fund, and an undisclosed strategic investor. In addition, some existing investors such as U.S. Venture Partners, Amzak Health, Treo Ventures, and Aperture Venture Partners also participated in this round of financing. ShiraTronics, located in Minneapolis, Minnesota, is a clinical-stage medical device company focused on developing neurostimulation therapies for chronic migraine patients. It is committed to improving the lives of chronic migraine patients and received the FDA breakthrough device designation in 2021. The name of the disease migraine is not unfamiliar, and it is often heard in life, so the migraine market is also quite extensive worldwide. According to ...
- Source: drugdu
- 53
- October 15, 2024
【EXPERT Q&A】How to obtain the 510K number for medical device export to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States and obtaining a 510K number involves adhering to the regulations and procedures set forth by the U.S. Food and Drug Administration (FDA). Ⅰ. Understanding the Basics of 510K 510(k) is a premarket notification program established by the FDA, named after Section 510(k) of Chapter 21 of the Federal Food, Drug, and Cosmetic Act. This program requires manufacturers to submit a “510(k) Premarket Notification” to the FDA before introducing a new medical device or making significant modifications to an existing one and reintroducing it to the market. The purpose of this submission is to demonstrate that the newly developed medical device is substantially equivalent in safety and effectiveness to a similar device that has already been approved by the FDA. Ⅱ. Determining Product Classification First, it is essential to determine the classification of the medical device. The FDA categorizes medical devices ...
- Source: drugdu
- 87
- October 7, 2024
【EXPERT Q&A】What is the role, definition, and inquiry of the FDA Consensus Standard for medical devices?

Drugdu.com expert’s response: FDA medical device consensus standards play a pivotal role in the medical device industry. Ⅰ. The Role of FDA Medical Device Consensus Standards Ensuring Safety and Effectiveness: These standards assist manufacturers in ensuring that their medical devices meet safety and effectiveness requirements during design, manufacturing, and usage, thereby safeguarding the health of patients and users. Streamlining Regulatory Processes: Manufacturers can leverage these consensus standards to fulfill FDA regulatory requirements, reducing the need for redundant testing and evaluations, which accelerates pre-market approval timelines. Enhancing Transparency: Consensus standards provide clear benchmarks for medical device performance and safety, contributing to increased industry transparency and fostering fair competition. Facilitating International Harmonization: Many FDA-recognized medical device consensus standards are international, simplifying international trade and market access, thereby promoting coordinated development of the global medical device market. Ⅱ. Definition of FDA Medical Device Consensus Standards FDA medical device consensus standards refer to a ...
- Source: drugdu
- 78
- October 2, 2024
【EXPERT Q&A】What is the difference between medical devices and non-medical devices?

Drugdu.com expert’s response: The differences between medical devices and non-medical devices are primarily manifested in the following six aspects: Ⅰ. Definition and Purpose Medical Devices: Refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related articles, including the necessary computer software, that are directly or indirectly used on the human body. Their efficacy is primarily obtained through physical means rather than through pharmacology, immunology, or metabolism, or if these means are involved, they only play an auxiliary role. The primary purposes include diagnosis, prevention, monitoring, treatment, or alleviation of diseases, as well as diagnosis, monitoring, treatment, alleviation, or functional compensation of injuries. Non-Medical Devices: Generally refer to products that are not directly used on the human body or, even if in contact with the human body, do not have a medical purpose. They may be daily necessities, industrial products, consumer goods, such as ...
- Source: drugdu
- 77
- September 27, 2024
【EXPERT Q&A】Why should medical device companies make full use of data value under the normalization of collection?

Drugdu.com expert’s response: In the context of normalized centralized procurement, the importance of medical device enterprises leveraging data value has become increasingly prominent. This primarily stems from the following considerations: Ⅰ. Market Trend Insight and Precise Positioning Market Analysis Reports: CRM systems or other data analytics tools can provide detailed market analysis reports, enabling enterprises to promptly understand market size, competitive landscape, and trend changes. This aids enterprises in precisely positioning themselves in the market under centralized procurement policies, adjusting product portfolios and marketing strategies to better align with market demands. Competitive Landscape Analysis: Through data analysis, enterprises can grasp competitors’ dynamics, including their product layouts, market shares, pricing strategies, etc., thereby formulating more targeted competitive strategies. Ⅱ. Customer Demand Response and Satisfaction Enhancement Customer Analysis Reports: Enterprises can gain deep insights into customer preferences, purchasing behaviors, and satisfaction levels, providing data support for product design, customized services, and after-sales ...
- Source: drugdu
- 76
- September 23, 2024

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