Category: Uncategorized
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Understanding the Critical Role of Post Market Surveillance in the Medical Device Industry
Launching your medical device into the market is just the beginning, not the conclusion, of your groundbreaking journey. Despite the immense effort poured into development, regulatory approvals, and manufacturing, it’s crucial to recognize that the journey doesn’t conclude with market entry. Beyond the initial milestones, regulatory bodies mandate an ongoing commitment known as post-market surveillance…
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MedTech News Briefs | January 29th, 2024
Monday, January 22nd Researchers from Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield are leading a £2 million ($2.6 million) trial, funded by the National Institute for Health and Care Research and the Medical Research Council, to test a treatment for stroke survivors using transcutaneous vagus nerve stimulation delivered as a self-delivered…
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MedTech News Briefs | January 22nd, 2024
Monday January 15th Canon Medical and Olympus have collaborated to develop the Aplio i800 Endoscopic Ultrasound (EUS) system. The partnership aims to provide advanced EUS equipment for high-quality image diagnoses, with a focus on technological advancements and diagnostic performance in the EUS field, starting with the European market in Q1 2024. The FDA has granted…
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Clinical Trials for Your Medical Device: An Introduction
Being a part of medical device development isn’t easy. It requires a lot of failure and trials. One trial that every developer will face is that of clinical trials. Clinical trials helps you to evaluate the safety and efficacy of interventions and is a requirement by regulatory bodies. In this article we dive into what…
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MedTech News Briefs | January 15th, 2024
January 8th, 2024 MET and Cormica Group have each made investments to enhance their medical device testing capabilities. MET has unveiled two walk-in Real-Time Ageing Chambers to expand its capacity for stability testing, while Cormica Group invested £235,000 in a dedicated building for its stability test programs in response to increased demand. Laborie Medical Technologies…
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Polymers for Medical Devices: Navigating Challenges and Embracing Solutions
In the complex world of medical device engineering, the use of polymers presents both challenges and transformative solutions. The demands are high: materials must endure rigorous sterilization procedures, interact well with the human body, and maintain mechanical performance. This article explores the challenges of using polymers in medical devices and the practical benefits they bring…
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MedTech News Briefs | January 8th, 2024
Tuesday January 2nd EQT will acquire Zeus Industrial Products, a leading provider of advanced polymer components, in a deal expected to close in Q1 2024. John Groetelaars, former CEO of Hillrom, will serve as Zeus’ executive chairman upon closing, and EQT plans to support Zeus with investments in additional capacity, R&D, and operational excellence. Glucotrack…
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Navigating the CE Marking Process: An Introduction for Medical Device Startups
In the medical device industry one crucial marker stands out – the CE marking. This insignia is not just a symbol; it is a gateway to the expansive European Union (EU) market, signifying adherence to rigorous standards for safety, health, and environmental protection. For medical device startups eyeing market expansion, understanding the intricacies of the…
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MedTech News Briefs | January 2nd, 2024
Happy 2024 Everyone! Due to last week being a holiday week this week’s news post is shortened. CVRx has received FDA approval for revised instructions for use for its Barostim neuromodulation system, incorporating long-term data from its BeAT-HF randomized clinical trial. The Barostim system delivers electrical pulses to baroreceptors in the carotid artery wall, activating…
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2024 for Think MedTek
Happy New Year and welcome to 2024 everyone! Around the end of each year and as we approach a new year I like to sit down and take time to think about what I want to do for each year. For me I try to include several areas of my life including family, fitness, faith,…
