Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

OUS Approvals Analysis: Expanded CoreValve Indication And Zika IVDs Among August’s CE Marks

Executive Summary

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.

You may also be interested in...



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.

BTG Set To Launch First Radiopaque Drug-Eluting Bead In The EU

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.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

MT103829

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel