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【EXPERT Q&A】What is the relationship between FDA registration and 510K registration for medical devices and what is the difference?

Drugdu.com expert’s response: The relationship between FDA registration and 510(k) clearance for medical devices involves overlap but also key distinctions. Relationship: 1.FDA Registration: This encompasses the process of submitting product information to the U.S. Food and Drug Administration (FDA) and obtaining FDA approval. It includes various types of registrations, such as 510(k) clearance, Premarket Approval (PMA), among others. 2.510(k) Clearance: This is a specific certification process within FDA’s regulatory framework, typically applicable to certain medical devices for which there are similar existing products on the market. In the 510(k) clearance process, manufacturers need to demonstrate that their product is substantially equivalent to an existing marketed device and does not pose an unreasonable risk to the user. Differences: 1.FDA registration is a broader concept encompassing various registration pathways, of which 510(k) clearance is one. 2.Within FDA registration, if a medical device can demonstrate substantial equivalence to a predicate device and meets ...
- Source: drugdu
- 223
- April 30, 2024
New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier

According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver cancer, and deaths related to viral hepatitis, affecting hundreds of millions. Early detection plays a crucial role in initiating timely treatments that improve long-term health outcomes. The detection of the hepatitis B virus surface antigen (HBsAg) in serum or plasma is an early indicator of infection. HBsAg is the first serological marker to appear in the progression of the disease, emerging in the blood two to three weeks before symptoms become apparent. Traditional testing protocols typically require retesting and subsequent confirmatory tests for reactive samples. Now, two newly introduced hepatitis assays use advanced technology to elevate efficiency and confidence in hepatitis testing. Beckman Coulter Diagnostics (Brea, CA, USA) has extended the menu of DxI 9000 Immunoassay Analyzer assays with ...
- Source: drugdu
- 149
- April 29, 2024
AI-Powered Digital Imaging System to Revolutionize Cancer Diagnosis

The process of biopsy is important for confirming the presence of cancer. In the conventional histopathology technique, tissue is excised, sliced, stained, mounted on slides, and examined under a microscope to identify cancerous markers. This lengthy procedure often results in patients waiting weeks or months for their results, causing treatment delays and heightened anxiety. Now, a breakthrough digital medical imaging system promises to transform cancer detection by offering instantaneous results, facilitating timely and effective treatment across all cancer types. The Photon Absorption Remote Sensing (PARS) system, an innovative, built-from-scratch technology developed by researchers at the University of Waterloo (Ontario, Canada), marks a radical departure from traditional cancer detection methods, promising diagnoses within minutes and enabling rapid surgical intervention. The system utilizes lasers to irradiate tissue samples, producing a comprehensive, high-resolution data set. This data is then processed by an artificial intelligence (AI) system that converts it into a conventional histopathology ...
- Source: drugdu
- 134
- April 29, 2024
Merck plans €300m investment at new German research centre

Merck KGaA (Merck) has announced an investment of more than €300m ($320.8m) in a new Life Science Research Center at its global headquarters in Darmstadt, Germany. Set to open in 2027, the centre will be a hub for developing biopharmaceuticals, including antibodies and messenger ribonucleic acid applications. The investment is part of Merck’s broader €1.5bn commitment to the Darmstadt site by 2025. Covering an area of 18,000m², the Advanced Research Center will consolidate efforts on key life science technologies such as the production of antibodies, recombinant proteins, and viral vectors. It allows collaboration across departments of the company in an open, modern work environment. The facility will also focus on the advancement of cell culture media, pharmaceutical formulation, purification aids, and analytical chromatography. Merck said the new centre will support both European and global customers in addressing significant medical challenges. Merck CEO and executive board chair Belén Garijo said: “With ...
- Source: drugdu
- 158
- April 29, 2024
Chiatai Tianqing’s Class 1 Innovative Drug TQA3038 (siRNA) Completes Phase I Clinical Study

Recently, Chiatai Tianqing Pharmaceutical Group’s self-developed Class 1 innovative drug TQA3038 (siRNA) successfully completed Phase I clinical study. The company will start the follow-up clinical study of TQA3038 injection in patients with chronic hepatitis B in the near future. TQA3038 injection is a small interfering RNA (siRNA) drug independently developed by Chiatai Tianqing to target hepatitis B virus (HBV), with the indication of chronic hepatitis B. TQA3038, as an N-acetylgalactosamine (GalNAc)-conjugated siRNA drug, can be enriched in the liver, degrade the targeted RNA, inhibit translation of the relevant proteins, thus blocking the replication of hepatitis B virus. TQA3038 adopts a nucleic acid sequence with independent intellectual property rights and has strong in vitro and in vivo antiviral activity. The “randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic profile of TQA3038 in healthy adult subjects” initiated by the Company has been successfully completed recently. The ...
- Source: drugdu
- 212
- April 29, 2024
Nestlé India and Dr Reddy’s announces joint venture

The partnership will bring together the global range of nutritional health solutions as well as vitamin, minerals, herbals and supplements of Nestlé Health Science (NHSc) with the commercial strengths of Dr. Reddy’s in India Nestlé India and Dr. Reddy’s Laboratories both together referred as “JV Partners”, today announced that they have entered into a definitive agreement to form a joint venture (“JV Company”) to bring innovative nutraceutical brands to consumers in India and other agreed territories. The partnership will bring together the global range of nutritional health solutions as well as vitamin, minerals, herbals and supplements of Nestlé Health Science (NHSc) with the commercial strengths of Dr. Reddy’s in India. The joint venture will help JV Partners combine their strengths and grow their complementary nutraceuticals portfolios in categories such as metabolic, hospital nutrition, general wellness , women’s health and child nutrition for consumers across India. The JV Company will be ...
- Source: drugdu
- 143
- April 29, 2024
Parexel partners with Palantir to accelerate clinical data delivery

Under the collaboration, Parexel will leverage Palantir’s Foundry and Artificial Intelligence Platform (AIP) to further power its clinical data platform, focused on driving clinical trial efficiency while maintaining the safety and regulatory rigor Parexel and Palantir Technologies has announced a multi-year strategic partnership to leverage AI to help enhance and accelerate the delivery of safe and effective clinical trials for the world’s biopharma customers. Under the collaboration, Parexel will leverage Palantir’s Foundry and Artificial Intelligence Platform (AIP) to further power its clinical data platform, focused on driving clinical trial efficiency while maintaining the safety and regulatory rigor. Parexel is the first CRO working with Palantir in this capacity, building on the companies’ existing collaboration over the past year. Jonathan Shough, Chief Information Officer for Parexel said, “We’re thrilled to expand our collaboration with Palantir — a leader in artificial intelligence technology — as we build on our application of AI ...
- Source: drugdu
- 136
- April 29, 2024
【EXPERT Q&A】What is the specific process of ce certification for medical devices?

Drugdu.com expert’s response: The specific process of CE certification for medical devices typically includes the following steps: 1.Preparation of Application: Manufacturers first need to prepare comprehensive application materials, including technical documentation, product specifications, quality management system documents, etc. 2.Selection of Certification Body: Choose an appropriate certification body for CE certification, ensuring that it is accredited and recognized. 3.Evaluation and Testing: The certification body will conduct evaluation and testing of the product to ensure compliance with the relevant European Union Medical Device Directives. 4.Compilation of Technical Documentation: Manufacturers need to compile complete technical documentation, including product descriptions, design files, test reports, etc. 5.Conducting Audit: The certification body will audit the manufacturer’s technical documentation to ensure its completeness and compliance with requirements. 6.Issuance of Certificate: If the product passes the audit and meets the requirements, the certification body will issue a CE certification certificate, confirming that the product complies with relevant standards ...
- Source: drugdu
- 166
- April 29, 2024
Pharma Asia 2024

Organiser: Ecommerce Gateway Pakistan Time:20 – 22 August 2024 address：University Rd, Gulshan-e-Iqbal, Karachi- Pakistan Exhibition hall: Karachi Expo Center Product range: Medical Products exhibition area: Medical diagnostic equipment and supplies, electronic medical equipment and instruments, rescue equipment, medical reagents and equipment, etc Hospital supplies exhibition area: catheters, interventional materials, surgical hygiene products, disposable medical consumables, surgical tools, medical clothing and bedding, first aid equipment, maternal and child care equipment, disinfection equipment, etc Experimental equipment exhibition area: laboratory instruments and equipment, optical instruments and equipment, image analysis and processing system, test instruments and devices, laboratory update and transformation technology, consumables and related software, etc Medicine exhibition area: all kinds of new special medicine, proprietary Chinese medicine, Western medicine, traditional Chinese medicine health products, nutritional food, etc. Traditional medicine: Chinese medicine, herbal medicine, etc Pharmaceutical equipment exhibition area: drug production equipment and technology, drug packaging equipment, drug packaging materials, drug production, cleaning, ...
- Source: drugdu
- 208
- April 29, 2024
Exo adds FDA-cleared AI tools to handheld ultrasound system

Dive Brief Exo has made new artificial intelligence tools available on its Iris handheld ultrasound system, the company said Tuesday. The Food and Drug Administration cleared Exo’s AI tools for analyzing ultrasound images of the heart and lung last year. Exo sees the new capabilities as particularly beneficial for health systems and caregivers in rural and under-resourced settings because they simplify the collection and interpretation of images. Dive Insight Exo received a 510(k) nod for its original Iris device in 2021 and added imaging modes and indications to the clearance the following year. The clearances cover handheld portable diagnostic ultrasound systems, similar to Butterfly Network’s iQ, that enable healthcare professionals to measure body structures and fluids in adults and children. Users can view the images on smartphone screens. In 2023, Exo gained additional FDA clearances for AI products. One clearance covered software that uses machine learning to help quantify bladder ...
- Source: drugdu
- 162
- April 28, 2024

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