Refine by
Medical Product Articles & Analysis
278 news found
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. ...
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 ...
Medical device testing is a crucial step in the development and commercialization of innovative medical devices. ...
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. ...
Their support is instrumental to making this improved access a reality,” said Philippe Menu, M.D., Ph.D, Chief Medical and Chief Product Officer, SOPHiA GENETICS. “Additionally, the breadth and depth of real-world data that we will generate through the implementation of this decentralized liquid biopsy testing platform on a global scale will be ...
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 ...
These services are designed to help medical device manufacturers meet regulatory requirements and ensure the safety and effectiveness of their products. Medical device safety testing is a critical component of the product development process, ensuring that medical devices meet regulatory requirements and are safe ...
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. ...
BySTEMart
In addition, it elucidates trends in electronics, medical, automotive, and consumer product industries, exploring components, devices, key market players, regulatory standards, and environmental considerations. ...
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 ...
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 potential toxicity of these novel drug delivery platforms. ...
We believe we can provide a safer alternative to other THC products providing the benefits without the negative psychiatric side effects. ...
Food and Drug Administration (FDA), the European Commission, and the Chinese National Medical Products Administration (NMPA). In the summer of 2022, Bayer received approval from the U.S. ...
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 ...
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 ...
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 ...
ByBayer AG
For stubborn deep-seated blemishes, if you want to see faster results, you can try using medical aesthetics, such as the highly targeted picosecond laser program to remove blemishes. ...
Food and Drug Administration (FDA) in July 2021, the European Commission in February 2022, and the Chinese National Medical Products Administration (NMPA) in June 2022. In September 2022, Bayer announced that it received approval from the U.S. ...
ByBayer AG
C-Path orchestrates the development of drug development tools through an innovative, collaborative approach to the sharing of data and expertise, and accelerates the pace and reduces the costs of medical product development by building consensus among the participating institutions. ...