OUS Approvals Analysis: Expanded CoreValve Indication And Zika IVDs Among August’s CE Marks
August was another slow month for announcements of medical device approvals outside the US, but the short list of non-US approvals this month includes a broad range of device-types approved, notably a much-awaited expanded indication for Medtronic’s CoreValve Evolut R, in six different territories.
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OUS Approvals: Neurostim And Cardiovascular Lead June Surge
Approvals of neurostimulation and cardiology devices dominated the list of non-US medtech approvals in June. According to Medtech Insight's Approvals Tracker, there were 36 medtech approvals outside the US last total that month, including 28 CE marks in Europe, plus approvals from China, Canada, Australia/New Zealand and Brazil.
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DC Bead Lumi is designed to be loaded with doxorubicin or irinotecan to treat liver cancer while showing the treating physician where it is to improve control of transarterial chemoembolization procedures.
Zika Assay Reviews Are Testing The Limits Of FDA Capacity, Shuren Says
As Congress squabbles over a federal funding bill to fight the virus, FDA reviewers are taking on extra duties and working overtime to approve Zika diagnostics quickly, device chief Jeff Shuren says. The most recent emergency-use authorization targeting Zika extended the usability of a Hologic assay to more patients.