1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Approvals

Global Device Approvals Q2 Shapshot: Coronary Devices Abound

 
• By Reed Miller

The second quarter of 2018 brought 62 approvals from outside the US, including 46 in Europe, according to Medtech Insight's Approvals Tracker. Among those approvals, 14 were for devices to treat coronary artery disease, and the second most-common indications were obesity and soft-tissue repair. Outside of Europe, Japan had the most non-US approvals in the quarter with five.

Earth Tic Marks
• Source: shutterstock.com

Devices to treat coronary artery disease accounted for 14 of the 62 medical device approvals from outside the United States recorded in the second quarter of 2018 by Meddevicetrackerand Medtech Insight's Approvals Tracker, making it by far the most frequently non-US approved indication category during the quarter. 

Approvals of such devices over the last three months include Corindus Vascular Robotics Inc.'s CorPath GRX vascular robotic system, which received approval from Japan's Pharmaceutical and Medical Device Agency...

US Look

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 Approvals

More from Policy & Regulation

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.