1. Medtech Insight
  2. >>Business
  3. >>R&D

OUS Approvals Analysis: Summer Brings Slowdown In CE Marks

 
• By Reed Miller

Medtech Insight’s new Approvals Tracker recorded 18 approvals outside the US, including five in vitro diagnostic approvals and five cardiovascular device approvals.

[Editor's note: Check out details on all US and non-US device and diagnostics approvals in 2016 at Medtech Insight's Approval Tracker: https://medtech.pharmamedtechbi.com/datasets/approvals.]

July was a relatively light month for approvals outside the US, with 13 coming from Europe and five from other...

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 R&D

Sofinnova And NVIDIA Partner To ‘Supercharge’ Computation For European Startups

 
• By Natasha Barrow

European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.

Somnee AI-Powered Sleep Wearable Raises $10M Seed Round

 
• By Natasha Barrow

The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.

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.

More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?

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.