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BioWorld - Sunday, December 14, 2025
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Nov. 27, 2018

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FDA updates device safety plan as ICIJ publishes string of negative reports on med-tech industry

Device makers are receiving some interesting signals about the regulation and reputations of their offerings from the FDA and from another group in the last week of November. The FDA has published another update to its medical device safety action plan that includes a proposal to publicly disclose a list of 510(k) devices that cite predicates that were 10 years old at the time. The FDA announcement arrives one day after the International Consortium of Investigative Journalists (ICIJ) released several reports on device recalls, including one report about Medtronic, titled "Medtech Giant Pushes Boundaries As Casualties Mount And Sales Soar." Read More

Perkinelmer's noninvasive prenatal testing system approved for EU market

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Berry Genomics and Prenetics establish JV in China for genetic testing services

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Omass applying gas mass spec tech to human health with $18M series A round

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Factor halts development on advanced wound healing therapy following trial failure

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Daily M&A

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Financings

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Other news to note

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BioWorld MedTech's Neurology Extra

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