Recently, Integer Holdings Corporation, the world’s largest CDMO company with deep roots in cardiovascular devices, announced that it will divest its non-medical business. The company has reached an agreement to sell its Electrochem business, which focuses on the energy, military and environmental fields, to Ultralife Corporation for $50 million in cash, and the transaction is expected to be completed by the end of October. Joe Dziedzic, president and CEO of Integer, said that after the transaction is completed, Integer will be a pure medical company with additional cash to repay debt and execute our inorganic growth strategy. Ultralife is an ideal buyer for Electrochem because they are a leader in providing critical power solutions to a variety of industries including energy, defense and environmental markets. As a global medical device CDMO leader, Integer’s medical customers include large multinational medical device OEMs and their subsidiaries, including Abbott, Johnson & Johnson, Boston ...
Recently, the National Medical Insurance Administration issued the “Reply of the National Medical Insurance Administration to Suggestion No. 2090 of the Second Session of the Fourteenth National People’s Congress” (hereinafter referred to as the “Reply”). In the “Reply”, the National Medical Insurance Administration explained the next steps for the centralized procurement of consumables and the implementation of innovative medical devices. In particular, the next steps for local centralized procurement were explained. The “Reply” pointed out that centralized procurement is still in the stage of reform and overcoming difficulties. The National Medical Insurance Administration will further supervise and improve the rules of local centralized procurement, improve the scientificity and standardization of local centralized procurement, and improve the quality and efficiency of procurement. First, expand the scope of the alliance and strengthen national coordination. Encourage local governments to carry out alliance procurement, and upgrade to national alliance procurement if conditions are met. ...
At the end of September, the National Joint Procurement Platform for High-value Medical Consumables issued the “Notice on the Centralized Maintenance of Cochlear Implants and Peripheral Interventional Medical Consumables”. At present, many provinces have begun to start the historical procurement data reporting work for this national procurement. The reporting subjects are public medical institutions that use cochlear implants and peripheral interventional medical consumables in 2022 and 2023. The deadline is around October 16 and 17. At 15:00 on October 8, the National Joint Procurement Office for High-value Medical Consumables will introduce the system operation through video conferencing, and provide training videos and other materials for use by various medical institutions. Peripheral intervention is one of the few varieties that have not yet been purchased on a large scale. This national procurement is bound to have a major impact on this field. In 2021, Henan’s centralized procurement of neuro-interventional and peripheral ...
In recent days, various stimulus policies designed from the top have been launched, giving the long-dull stock market a long-lost vitality. On September 30, the Shanghai Composite Index closed up 8.06%, standing above 3,300 points, with a cumulative increase of more than 17% in September; the Shenzhen Component Index closed up 10.67%, with a cumulative increase of more than 26% in September; the ChiNext Index closed up 15.36%, with a cumulative increase of more than 37% in September; all set a record for the largest single-day increase in history. On that day, the turnover of the two markets was 2.593 trillion yuan, setting a record high since 2006. The activity of funds has risen unprecedentedly, and once exceeded the carrying capacity of the exchange server during the session. Players in the market are gearing up to “do a big job”. However, the pharmaceutical industry has been subject to many restrictions ...
Drugdu.com expert’s response: The process of exporting and registering pharmaceutical products in South Africa is a relatively complex and meticulous endeavor, involving multiple stages and documentation requirements. Here is an overview of the process: Ⅰ. Preliminary Preparation Product Classification: Firstly, it is crucial to determine the classification of the pharmaceutical product in South Africa, as different classifications may entail different registration requirements and procedures. Preparation of Technical Documentation: This typically includes detailed information about the product, such as its composition, indications, dosage form, quality standards, as well as technical specifications, design descriptions, and performance test results that demonstrate the product’s safety, efficacy, and performance. Collection of Clinical Data: Depending on the requirements, relevant clinical data must be provided to support the product’s clinical performance and effectiveness. This may encompass clinical trial results, case studies, literature reviews, etc. Corporate Qualification: Ensure that the exporting company has a legal registration status in ...
The existing electrophysiology market is very considerable, and the incremental market has unlimited potential. Research institution BTIG predicts that half of atrial fibrillation ablations may be replaced by PFA in the next three years. In the new business of PFA, electrophysiology giants dare not be tired at all. Recently, Boston Scientific announced that it has obtained approval from Japanese regulators for the FARAPULSE™ pulsed field ablation system. Nick Spadea-Anello, president of Boston Scientific Electrophysiology, said that the FARAPULSE PFA system is the most clinically studied PFA system. To date, it has been used to treat more than 125,000 patients worldwide and continues to strengthen its strong safety, effectiveness and efficiency characteristics. “The rapid adoption of the FARAPULSE PFA system, which is now approved in more than 65 countries, demonstrates a paradigm shift in the treatment of paroxysmal atrial fibrillation – an approach that has clinical benefits for both physicians and ...
According to the National Medical Products Administration’s Licensed Pharmacist Qualification Certification Center, from the end of April to the end of July this year, the cumulative number of licensed pharmacists in the country with valid registration has decreased month-on-month. In April, May, June, and July, the number of registered licensed pharmacists nationwide decreased by 1,940, 685, 4,384, and 88 respectively. In recent years, the number of retail pharmacies in my country has continued to grow. As of the end of December 2023, the number of pharmacies nationwide exceeded 666,000, including 14,792 wholesale enterprises, 6,725 retail chain headquarters, 385,594 retail chain stores, and 281,366 single pharmacies. These data have increased compared to 2022. The total number of retail pharmacies continues to increase, and the society has a strong demand for licensed pharmacists, but the number of registered licensed pharmacists has decreased in several months. The General Department of the State Drug ...
Organiser:Hannover Milano Fairs Time:May 27 – 30, 2025 Address:Strada Statale Sempione, 28, 20017 Rho MI Exhibition hall:Fiera Milano Rho Product range: Pharmaceutical Raw Material Equipment: Reaction equipment, drying equipment, crystallization equipment, centrifuges, extraction equipment, heat exchangers, storage equipment, filtration equipment, evaporation equipment, distillation equipment, screening machinery, sterilization equipment, filter press equipment, homogenizers, etc. Pharmaceutical Dosage Form Equipment: Pill machinery, ointment machinery, eye drop machinery, tablet machinery, tincture, syrup machinery, granule machinery, soft capsule machinery, aqueous injection machinery, hard capsule machinery, suppository machinery, oral liquid machinery, medicinal film machinery, aerosol machinery, antibiotic powder machinery, coating machines, pharmaceutical filling machines, jet mills, pharmaceutical grinders, low-temperature grinders, pharmaceutical grinding units, mechanical pharmaceutical grinders, ultra-fine grinders, granulators, mixing equipment, bottle conveying machines, bottle arranging machines, bottle washing machines, aeration devices, capping machines, feeding devices, etc. Pharmaceutical Packaging Machinery: Weighing equipment, bag packaging machines, pillow packaging machines, blister packaging machines, bottling lines, printing machines, ...
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 ...
On September 8, the Ministry of Commerce, the National Health Commission, and the State Food and Drug Administration jointly issued the Notice on Carrying out Pilot Work on Expanding Opening-up in the Medical Field (hereinafter referred to as the “Notice”). It is proposed to allow the establishment of wholly foreign-owned hospitals (except for traditional Chinese medicine, excluding mergers and acquisitions of public hospitals) in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and Hainan. This is undoubtedly a bold innovation to the existing healthcare system. Previously, foreign investment was limited to joint venture hospitals, and there were many restrictions such as shareholding ratio. With the relaxation of policy restrictions and the introduction of foreign-funded medical institutions, as more high-end medical institutions enter the Chinese market, while diverting some high-end patients, it may also improve the development and progress of the overall medical level in China. There are two main points ...
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