FDA Town Hall Series on Ethylene Oxide Sterilization and Alternative Sterilization Modalities
Explore FDA efforts to reduce EO use in medical device sterilization, the rise of VHP, and how NAMSA can assist with sterilization validation.
Category: Industry Reposts
European Heart Journal: Randomized Controlled Trials Are Not Always the Solution
European Heart Journal Article | Published 13 December 2023 By Sara Finocchietti (NAMSA Senior Strategy Consultant, Clinical) The recent article authored by Siontis et al.1 has made considerable contributions to the ongoing debate concerning the pre-market clinical evaluation of implantable medical devices in Europe, with a particular focus on the cardiovascular domain. The study encompassed seven different … Continued
WOUNDS UK: Models and Methods to Support the Development of Novel Burn Wound Antimicrobial Treatments
WOUNDS UK Journal Article Vol: 19 | Issue: 04; November 2023 By Jennie Ritchie (NAMSA Global Associate Product Marketing Manager – QCSA Laboratory Services), Samantha Westgate (Former NAMSA Scientific Director, Microbiology and In Vitro Development) and Jim Pomonis (Former NAMSA Associate Vice President, Scientific Affairs) Despite the advances in burn wound management, infection is a … Continued
The New England Journal of Medicine: Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia
Limflow, developer of the Limflow System for treatment of Chronic Limb-Threatening Ischemia (CLTI), partnered with NAMSA during this pertinent clinical study. With a dedicated focus on medical device and IVD products, NAMSA has designed and conducted trials in every area of the world to address wide-ranging client objectives. Our clinical experts are uniquely positioned to understand … Continued
PharmTech Outlook: Cover Story Featuring NAMSA President & CEO, John Gorski
Over the last decade, the pharmaceutical and medical device industries have undergone significant transformative trends and innovations. These shifts have rapidly improved efficiency and lowered costs while bringing an increased focus to personalized patient care. According to a 2019 study by Research and Markets, sales in the pharmaceutical industry are expected to rise to $900 billion in 2019 to $1.2 trillion by 2024, while the global medical device market is expected to grow at a CAGR of 5.33 percent to $521.64 billion by 2022.