Recently, Terry Yuan, the founder and CEO of Ddu, revealed that Ddu (www.drugdu.com) has raised 10 million yuan in Series Pre-A round of financing, which will be used to improve the service and build a strong team. Ddu is a global leading pharmaceuticals and medical devices online B2B platform.
Organiser:Sichuan Hospital Association, Sichuan Medical Device Industry Association, Sichuan Rehabilitation Medical Association Time:26- 28 September 2024 address:198 Century City Road, Chengdu City, Sichuan Province Exhibition hall: Chengdu Century City new international Convention and Exhibition Center Product range: Medical equipment exhibition area: imaging equipment, in vitro diagnostic reagents and instruments, disinfection sensor series, medical electronic equipment, medical vehicles, operating rooms and emergency equipment, medical consumables and surgical consumables, medical maintenance accessories and consumables, etc Medical Examination Exhibition area: Medical analysis system, genetic and life science instruments, laboratory case equipment and consumables, pre-examination equipment and consumables, blood collection management system and transfusion supplies, blood and cell analysis system, pre-examination equipment accessories and maintenance consumables, etc Rehabilitation and well-being exhibition area: sensory integration training equipment, equipment and supplies for the disabled, rehabilitation physiotherapy equipment, sensory interactive equipment, assistive devices, etc. Sensory integration training equipment, equipment and supplies for the disabled, rehabilitation physiotherapy equipment, ...
The Environmental Protection Agency recently implemented new regulations to limit emissions of a common but cancer-causing medical device sterilant, after years of health meetings, lawsuits and debate about how to handle the issue. Medical device companies will need to comply with new requirements governing ethylene oxide (EtO) emissions, and some device sterilizers are searching for suitable alternatives. In April, the EPA published a final rule that sets new limits for medical device sterilizers that use EtO. Now, companies will have three years to comply with the new standards. The agency is also working on a separate set of requirements to reduce EtO exposure for workers in sterilization plants. Long-term exposure to the chemical can increase a person’s lifetime cancer risk. In the meantime, the Food and Drug Administration has been evaluating other ways of sterilizing medical devices and changes companies can make to reduce EtO emissions. It has also launched ...
Drugdu.com expert’s response: The U.S. FDACFR21 regulations refer to Title 21 of the Code of Federal Regulations (CFR), which encompasses regulations established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This set of regulations, overseen by the U.S. Food and Drug Administration (FDA), governs various aspects of the production, distribution, labeling, advertising, and safety of food, drugs, medical devices, cosmetics, and other related products. CFR Title 21 includes provisions covering: 1.Drug Quality and Manufacturing Practices: Regulations concerning quality control, processes, equipment, raw materials, packaging, and other aspects of drug manufacturing. 2.Food Labeling and Ingredients: Requirements for information on food labels, ingredient lists, nutrition labeling, etc., ensuring consumers receive accurate information. 3.Medical Device Registration and Reporting: Mandates for medical device manufacturers to register and report, as well as comply with relevant quality management system requirements. 4.Cosmetic Safety and Labeling: Standards for cosmetic safety, ingredient restrictions, and labeling requirements to ...
Don Tracy, Associate Editor The catheters approved by the FDA include the Plato 17, a DMSO-compatible microcatheter, and the Socrates 38, an aspiration catheter specifically designed for treating ischemic strokes. Scientia Vascular announced that the FDA has approved two of its neurovascular catheters. According to the company, the Plato 17 microcatheter offers physicians the ability to control and stabilize neurovascular applications and is also DMSO compatible. The Socrates 38, which is currently in a limited market release, is an aspiration catheter for treating ischemic strokes. Scientia stated that the approvals mark a significant advancement in its medical technology portfolio.1 “Our FDA clearance is a significant milestone for Scientia Vascular. By applying proven microfabrication technology to catheters and designing our access and treatment devices for efficiency when used together, we’re providing physicians the next generation of neurovascular access tools.” said John Lippert, CEO, Scientia Vascular, in a press release. “I am ...
Dive Brief Senseonics has received an integrated continuous glucose monitoring (iCGM) designation from the Food and Drug Administration, the company said Tuesday. The designation, which the FDA granted via its de novo pathway, clears Senseonics to integrate its implantable CGM with pumps as part of automated insulin delivery systems. Senseonics’ sales are small compared to the CGM leaders Abbott and Dexcom, but BTIG analysts said the iCGM designation and planned one-year sensor could help the device appeal to a broader patient population. Dive Insight Senseonics’ Eversense device is a CGM implant that replaces fingerstick blood glucose measurements. The current device continually measures glucose levels for up to 180 days but requires daily calibrating with a fingerstick after day 21 and when symptoms do not match CGM information. Abbott and Dexcom sell shorter-lasting patches that dominate the CGM space. The iCGM designation allows Eversense to integrate with ...
Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. By Frank Vinluan Sleep apnea could be the next new indication for an Eli Lilly drug that’s already a blockbuster seller in metabolic indications. The pharmaceutical giant has preliminary Phase 3 data showing that treatment with the drug reduced the breathing interruptions characteristic of the common sleep disorder. With the positive data in hand, Lilly said it is now planning for regulatory submissions seeking to expand the label of tirzepatide, which is marketed as Mounjaro for type 2 diabetes and as Zepbound for weight management. Those submissions are expected in the middle of this year. Obstructive sleep apnea (OSA) is the collapse or partial collapse of the upper ...
Don Tracy, Associate Editor Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis. Alexion, AstraZeneca Rare Disease announced that the FDA has approved Voydeya (danicopan) as an add-on therapy for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH), in combination with ravulizumab or eculizumab. According to the company, the medication treats patients with significant EVH despite receiving C5 inhibitor therapy. The approval was based on positive results from the Phase III ALPHA trial, which found that Voydeya improved hemoglobin levels while providing the benefit of avoiding transfusions after a primary 12-week period. Additionally, there was no significant increases reported related to safety concerns, with common adverse reactions including headache, nausea, arthralgia, and diarrhea.1 “The approval of first-in-class, Factor D inhibitor Voydeya marks an important advancement in the treatment of PNH and builds on ...
Dive Brief 3M completed a spinoff of its healthcare business, Solventum, on Monday. The company started trading on the New York Stock Exchange under the ticker SOLV and was quoted at $67.96 a share at midday. The new company will sell 3M’s medical devices, including its stethoscopes, IV port protectors and negative pressure wound therapy devices. It also houses 3M’s dental, health IT and filtration products. Solventum CEO Bryan Hanson told investors in March the spinoff will be one of the top three in medical device history, citing its global scale and more than $8 billion in revenue last year. Dive Insight Solventum told investors last month that the standalone company expects organic revenue in a range of from minus 2% to 0% in 2024, and a free cash flow of from $700 million to $800 million. The four business units that make up the company — MedSurg, dental solution, ...
Drugdu.com expert’s response: The US QSR820 quality system refers to the Quality System Regulation issued by the United States Food and Drug Administration (FDA) for medical devices. This regulation, also known as the Medical Device Quality System Standard, sets forth the quality management system requirements that medical device manufacturers must follow to ensure the safety and effectiveness of medical devices. QSR820 covers various aspects including design controls, production controls, equipment calibration, quality audits, record-keeping, etc. ISO13485 is the medical device quality management system standard published by the International Organization for Standardization (ISO). It bears some similarities to QSR820 as both are quality management system standards for the medical device industry aimed at ensuring product quality and safety. However, ISO13485 is an international standard applicable to medical device manufacturers globally, whereas QSR820 is a regulatory standard mandated by the FDA specifically for medical devices marketed in the United States.
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