USA -
FDA Warns Duodenoscope Manufacturers Over Studies

All three manufacturers of duodenoscopes in the US drew warning letters on Friday for failing to conduct postmarket surveillance studies and submit the data to the US Food and Drug Administration (FDA).

Following nationwide outbreaks of infections associated with bacteria transmitted to patients who underwent surgery with contaminated duodenoscopes over the past few years, the agency has “taken important steps to improve the reprocessing of duodenoscopes,” FDA Center for Devices and Radiological Health Director Jeff Shuren said in a statement. The reusable and flexible tubes are used during surgical procedures that can be potentially life-saving.

A major step FDA took to help address the problem involved its October 2015 orders on the three US manufacturers -- Olympus, Fujifilm Medical Systems, and Pentax Medical -- to report study findings of healthcare facilities’ ability to properly clean and disinfect their duodenoscopes...

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Discovery -
Searching for the Future of Diabetes Management

Meet the six finalists in the Ascensia Diabetes Challenge, a global innovation competition designed to find digital solutions to transform Type 2 diabetes management. The future of diabetes management could be coming soon. A global innovation competition is underway to find digital solutions that can help transform type 2 diabetes management. Type 2 diabetes currently accounts for around 90% of the estimated 425 million people with diabetes globally, and new, innovative ways to manage this condition are urgently required to meet the substantial and growing burden to patients and our...

International -
Why B2B eCommerce is Perfect for Medical Device Companies

B2B eCommerce and the medical device industry are both growing. Frost & Sullivan predicts B2B eCommerce will be double the size of B2C by 2020 ($6.7 trillion versus $3.2 trillion). At the same time, an aging population and the development of new technologies are fueling growth in the medical devices and supplies market. According to IBISWorld research , the medical supplies market in the US alone was worth $192 billion in 2017. Forward thinking companies will see the convergence of these two trends and will make sure to be among the first to benefit from it. While B2B eCommerce is sure to...

International -
Considering Market Access Risk as Part of Today’s M&A Process

Understanding market access opportunities and barriers is a critical part of due diligence. The medical devices market experienced steady growth throughout 2017, with deals reached between some of the largest players in the market. The story has not changed much over the first six months of 2018, as the appetite for mergers and acquisitions ( M&A ) in the medical technology industry remains strong. From our insights into the industry, it appears this trend will continue into the second half of 2018 and 2019. The recent U.S. tax overhaul has resulted in M&A as a major driver of growth...

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