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Medical Has Launched Mass Production Articles & Analysis
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Many medical devices are manufactured through plastic injection moulding, which allows for precise and top-quality components in large-scale production and better aligns with ISO standards. In general, injection moulding for medical devices is conducted in an ISO 8 clean room environment to ensure all products adhere to the strictest standards of sterility and safety.This article covers how ...
U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has the same safety and effectiveness in terms of intended use, design, ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. These reliable testing solutions will meet the evolving needs of the medical device industry and help manufacturers ...
BySTEMart
MedSource Labs understands the critical importance of ensuring clinician access to high-quality medical supplies, as it directly impacts patient care and outcomes. In the face of global challenges, such as supply chain disruptions due to a spike in geopolitical conflicts, the time it takes to move products by sea and air has vastly increased. The costs related to the longer transit time has ...
SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced a new milestone in the global introduction of the liquid biopsy test MSK-ACCESS® powered with SOPHiA DDM™, first announced in October 2023. Under a definitive partnership agreement with AstraZeneca (LSE/STO/Nasdaq: AZN), SOPHiA GENETICS will ...
MedSource Labs Moves the Needle in the Peripheral Safety IV Market With the announcement of ClearSafe Comfort® and TrueSafe Comfort® Blood Control IV Catheters with groundbreaking active check valve ...
Protheragen-ING Lab, a well-known and reputable Good Laboratory Practices (GLP) service provider, has recently unveiled its cutting-edge medical device services. With a track record of excellence and reliability in providing high-quality services to the pharmaceutical and biotechnology industries, Protheragen-ING Lab is now expanding its offerings to include comprehensive solutions for medical ...
In a ground-breaking advancement for cardiovascular care, Hiden Analytical Ltd is proud to announce a surface measurement technique for devices critical in the treatment of heart disease. Utilizing the most sensitive surface analysis technology, Secondary Ion Mass Spectrometry (SIMS), Hiden Analytical is setting new standards in the safety, efficacy, and innovation of stent technology. Surgical ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Pilot Production Services for the medical device industry. These services allow manufacturers to test and refine their products prior to full-scale production, streamlining the development process of new medical devices and minimizing risk to save time ...
BySTEMart
Boston: “According to the latest BCC Research study, the demand for EMI/RFI: Materials and Technologies is estimated to increase from $7.4 billion in 2023 to reach $9.2 billion by 2028, at a compound annual growth rate (CAGR) of 4.6% from 2023 through 2028.” This comprehensive report delves into the dynamic landscape of the EMI/RFI materials and technologies market, meticulously ...
The U.S. Food and Drug Administration (“FDA”) has announced a new medical device product classification “whole room microbial reduction device” which establishes FDA regulation of UV robots intended to reduce the number of pathogens in unoccupied patient rooms, operating rooms and other areas in healthcare facilities where non-critical medical devices are present. ...
In recent years, the field of drug delivery has witnessed great advancements in the development of microspheres and microneedles, revolutionizing the way drugs are administered. These innovative technologies offer targeted and sustained release of therapeutic agents, promoting improved patient compliance and efficacy. However, as with any medical product, it is crucial to assess the safety and ...
We believe we can provide a safer alternative to other THC products providing the benefits without the negative psychiatric side effects. Pre-clinical trials have demonstrated the reversal of depression-like and schizophrenia-related symptoms, blockage of memory impairment, hyperactive activity, and gene vulnerability. CanaQuest Medical Corp ("CanaQuest" or the "Company") (OTC:CANQF), a ...
Phase III study FINE-ONE will evaluate the efficacy and safety of finerenone versus placebo in delaying the progression of chronic kidney disease (CKD) in adults with CKD and type 1 diabetes (T1D) CKD affects up to 40% of people with T1D A quarter of people with CKD associated with T1D progress to end-stage kidney disease Only limited treatment options are available for people with CKD and ...
ByBayer AG
Recently, the Ministry of Industry and Information Technology, the National Health Commission and other 17 departments jointly issued the "robot" application action implementation plan to encourage the development of surgery, auxiliary examination, auxiliary rounds, intensive care, rehabilitation and other medical robot products, "robot The "robot" has ushered in a new round of development ...
JUNE Medical is delighted to announce a new agreement with a major US hospital group to supply the award-winning Galaxy II® self-retaining surgical retractors to over 1,600 hospitals in the US, commencing April 15, 2023. This game-changing device radically improves the safety and ease of surgical retraction for both patients and medical staff; its ergonomic design transforms the way in which ...
Nubeqa now approved for metastatic hormone-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer Additional indication based on data from the pivotal Phase III ARASENS trial The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with docetaxel for the ...
ByBayer AG
The causes of hyperpigmentation are somewhat complex and may be related to UV rays, pregnancy, improper use of cosmetics, genetics and many other factors. You may have tried many methods but the results may not be satisfactory. It is not difficult to reduce blemishes. For stubborn deep-seated blemishes, if you want to see faster results, you can try using medical aesthetics, such as the highly ...
European Commission granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study FIGARO-DKD included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD ...
ByBayer AG
VeriSIM Life has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant for $255,908 to conduct research and development (R&D) work on rapid repurposing and translation of approved and investigational drugs for COVID-19 using its patented artificial intelligence (AI) driven biosimulation platform, BIOiSIM. VeriSIM Life has developed a whole-body ...