1. Medtech Insight
  2. >>Business

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

 
• By Reed Miller

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.

[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out the Approvals Tracker:https://medtech.pharmamedtechbi.com/datasets/approvals.]

Approvals of cardiovascular devices, in vitro diagnostics and new cancer treatments headline August's list of non-US approvals in Medtech Insight's...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Business

Three Steps To Investor Heaven For Medtech Founders: Articulate, Explain, Clarify

 
• By Ashley Yeo

Capital remains available for good healthtech projects, but it is more concentrated and harder to find than of late. Founders and inventors must know how to unlock it. The BioWales 2025 investor panel told them where they could be going wrong.

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 
• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

Thermo Fisher Cuts Annual Profit Outlook Amid Estimated $400M Tariff Hit

 
• By Shubham Singh

Thermo Fisher is aggressively managing its supply chain and cost base using its Practical Process Improvement (PPI) Business System. The company is also increasing investments in US-based manufacturing and R&D, with around $2bn allocated to bolster domestic operations.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

More from Medtech Insight

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.