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【EXPERT Q&A】What are the key points for the inspection of active medical devices?

Drugdu.com expert’s response: The inspection of active medical devices should focus on their safety, effectiveness, and compliance, requiring a systematic evaluation that integrates product characteristics, usage scenarios, and regulatory requirements. Below are the core inspection points: I. Electrical Safety and Protection Insulation Performance Test the insulation resistance between live parts and accessible components to ensure effective current isolation under both normal and fault conditions, preventing electric shock. Verify the durability of insulating materials under high-temperature and humid conditions to avoid insulation failure due to aging. Leakage Current Control Detect current flowing from live parts to non-live parts (e.g., housing) during operation, ensuring it remains below the human safety threshold (typically ≤0.5mA). Simulate single-point failures (e.g., insulation damage) to verify that the protective grounding system can safely divert leakage current to the ground. Voltage Withstand Capability Apply a test voltage higher than the rated voltage (e.g., 1.5 times the operating voltage) ...
- Source: drugdu
- 28
- August 13, 2025
Newly discovered drug class could someday lead to breakthrough treatments for fungal infections

A research team at McMaster University has discovered a new drug class that could someday lead to breakthrough treatments for dangerous fungal infections. The new molecules, dubbed coniotins, were isolated from a plant-dwelling fungus called Coniochaeta hoffmannii – the samples of which were collected from the McMaster greenhouse, located on the university’s campus. Detailed recently in the journal Nature Communications, the discovery responds to a critical need for new antifungal medicines. There is a huge, growing clinical need for new drugs that target fungal infections. Unlike antibiotics, of which there are dozens of different classes approved for use in clinics, there are really only three classes of antifungals on the market right now.” Gerry Wright, a professor of biochemistry and biomedical sciences at McMaster and principal investigator on the new study The reason for such a limited arsenal, Wright says, is two-fold. First, although disease-causing fungi are microscopic like bacteria ...
- Source: drugdu
- 34
- August 12, 2025
FDA Approves Ajovy for Migraine Prevention in Children and Teens

By Lori Solomon HealthDay ReporterMONDAY, Aug. 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved the single-dose Ajovy (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents. In the United States, one in 10 children and adolescents experience migraine, a common but often underrecognized and undertreated condition that can cause missed school, academic challenges, and social disruptions. Ajovy is the first and only calcitonin gene-related peptide antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults. Ajovy is authorized for adults and children/adolescents aged 6 to 17 years and weighing at least 45 kg (99 lb). Ajovy is a 225-mg/1.5-mL single-dose injection, available in a prefilled autoinjector or syringe, and can be given by a health care professional or self-administered or administered by a parent or caregiver in the home environment. “Pediatric migraine is a complex condition that can significantly ...
- Source: drugdu
- 34
- August 12, 2025
The results of Phase 1 clinical trials indicate that cancer vaccines can prolong the recurrence free survival of patients

On the 11th, Nature Medicine published a phase 1 clinical trial conducted by the research team of the University of California, Los Angeles. The results showed that a non individualized, mass produced, ready to use peptide vaccine called ELI-002 2P was helpful to extend the long-term relapse free survival of some patients with pancreatic cancer or colorectal cancer. It is known that the recurrence rate of pancreatic cancer and colorectal cancer is high even after surgery and chemotherapy, especially when there are trace cancer cells left in the body. The design of cancer vaccines aims to stimulate immune cell T cells, specifically recognize and kill cancer cells, and personalize targeting of tumor proteins in patients. KRAS gene in pancreatic cancer and colorectal cancer often carries mutations, which plays a key role in cancer growth, so it is an ideal target for cancer vaccines and other immunotherapies. Although inhibitors and T ...
- Source: drugdu
- 31
- August 12, 2025
Bloomage Biotech’s fermentation-based chondroitin sodium completes medical device master file registration

On the evening of August 11, Huaxi Bio(688363) announced that the company’s independently developed fermentation-based chondroitin sodium raw material (hereinafter referred to as “chondroitin sodium”) has successfully passed the National Medical Products Administration’s Medical Device Approval.The company has registered its master document with the Technical Review Center and has become the first company in my country to achieve regulatory compliance for its fermentation-based chondroitin sodium. Huaxi Bio said that the sodium chondroitin that has been registered this time is a new type of pharmaceutical-grade raw material of the company and can be used in Class II and Class III medical devices . It is expected to provide core raw materials for high-end medical devices in the future . It is reported that traditional chondroitin sulfate is mainly extracted from animal cartilage (such as pig, cow, chicken, and shark), which has problems such as animal immunogenicity, unsustainable raw material sources, and ...
- Source: drugdu
- 29
- August 12, 2025
Zhonghong Medical’s subsidiary, Kelun Medical Devices, plans to be selected for multiple medical consumables procurement projects

On August 11, Zhonghong Medical(300981) issued an announcement that its holding subsidiary Jiangxi Kelun Medical EquipmentKelun Medical Devices recently participated in bidding for the seventh and eighth rounds of Jiangsu Province’s medical consumables procurement program, as well as Shaanxi Province’s centralized volume-based procurement program for indwelling catheters and foam dressings. Based on the winning results, some of Kelun Medical Devices’ products, including disposable vacuum blood collection tubes and indwelling catheters, are expected to be selected for these centralized volume-based procurement programs. The winning prices and quantities have not been disclosed. The sales revenue of Kelun Medical Equipment’s disposable vacuum blood collection tubes and indwelling needles in 2024 were RMB 6.53 million and RMB 3.94 million, respectively, accounting for 3.55% and 2.14% of its operating income in 2024, and also accounting for 0.27% and 0.16% of the company’s operating income in 2024, respectively. During the procurement cycle of the proposed selected ...
- Source: drugdu
- 29
- August 12, 2025
A new drug for fatal brain tumors receives accelerated approval from the FDA, giving China Resources Sanjiu a leading position in localization.

On August 6th, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Jazz Pharmaceuticals’ (Jazz Pharmaceuticals) oral drug, Dordaviprone (trade name: Modeyso). This is the world’s first targeted drug for diffuse midline glioma (DMG) with the H3 K27M mutation. It is indicated for patients aged one year and older who have failed first-line therapy. Because these aggressive brain tumors are located in surgically restricted areas such as the brainstem and spinal cord, traditional treatment relies solely on palliative radiotherapy, resulting in a median survival of only approximately 12 months. This approval breaks a 25-year stalemate in this field, which had been characterized by the lack of a systemic treatment. Image source: Jazz Pharmaceuticals official website During its development, the US biotechnology company Oncoceutics was the first to discover the molecule’s dual anti-cancer mechanism: inhibiting the RAS signaling pathway by blocking the tumor-promoting DRD2 receptor while simultaneously activating the ...
- Source: drugdu
- 28
- August 12, 2025
Yifan Pharmaceuticals files for first generic application for melatonin granules, aiming to seize the children’s sleep market

The CDE’s official website recently announced that the marketing application for melatonin granules from Suzhou Yifan Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yifan Pharmaceutical, has been accepted. This Class 4 generic chemical drug, with 1g and 2mg dosages, targets sleep difficulties in Chinese children aged 6-15 with neurodevelopmental disorders. Melatonin, an endogenous hormone that regulates sleep-wake cycles, has clear clinical value in the treatment of childhood neurodevelopmental disorders. However, as of August 2025, only imported, originator-developed melatonin granules had been approved for marketing in China. Yifan Pharmaceuticals has applied for marketing authorization under the Class 4 chemical drug registration classification, becoming the first company in China to do so. There are a large number of children with neurodevelopmental disorders, including those with autism spectrum disorders and attention deficit hyperactivity disorder. Among these children, up to 50%-80% have sleep problems, of which difficulty falling asleep is the most common. Unlike ...
- Source: drugdu
- 29
- August 12, 2025
SINOPHEX CHONGQING

Organiser: China National Pharmaceutical Exhibition Co., Ltd. (Reed Sinopharm Exhibitions) Time：November 12–14, 2025 address：No. 66 Yuelai Avenue, Yubei District, Chongqing Exhibition hall：Chongqing International Expo Center Product range: API manufacturing equipment Traditional Chinese medicine decoction piece processing equipment Pharmaceutical packaging machinery Formulation equipment Other pharmaceutical production equipment Laboratory equipment and consumables Electronic supervision systems Pharmaceutical grinding equipment Environmental protection and purification systems Plastic machinery About Medical Fair India： The Chongqing International Pharmaceutical Equipment Exhibition (SINOPHEX) serves as a premier professional platform for learning, communication, and collaboration within China’s pharmaceutical equipment industry. Focused on industry hot topics such as green manufacturing, continuous-flow production, and intelligent manufacturing, SINOPHEX provides information and technological support to help Chinese pharmaceutical raw material and formulation producers achieve the goals outlined in the “Made in China 2025” initiative.
- Source: drugdu
- 30
- August 12, 2025
【EXPERT Q&A】What is the function of plasmid transfection reagents?

Drugdu.com expert’s response: Plasmid transfection reagents are core tools in molecular biology and gene engineering experiments, designed to efficiently deliver exogenous plasmid DNA into eukaryotic cells. Their functions span the entire process from cellular uptake to gene expression, as detailed below: I. Overcoming the cell membrane barrier to facilitate DNA transmembrane transport The phospholipid bilayer structure of the cell membrane inherently blocks large DNA molecules. Transfection reagents overcome this obstacle through physical or chemical mechanisms: Charge neutralization and complex formation: Plasmid DNA carries a negative charge, while transfection reagents (e.g., cationic liposomes, polyethyleneimine/PEI) are positively charged. They form stable nanoscale complexes via electrostatic interactions, neutralizing DNA’s negative charge and reducing electrostatic repulsion with the cell membrane, enabling cellular uptake through endocytosis. Membrane fusion or pore formation: Liposome-based reagents can fuse with the cell membrane, creating temporary channels for direct DNA release into the cytoplasm. Polymer-based reagents (e.g., PEI) may induce ...
- Source: drugdu
- 36
- August 11, 2025

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