1. Medtech Insight
  2. >>Policy & Regulation

Global Device Approvals Snapshot, 23-29 July 2019; Intersect ENT’s Straight Delivery System

 
• By Reed Miller

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of July 23 to 29 was another slow one for FDA approvals, with no new PMAs, panel-track PMA supplements, de novos, or non-US approvals.

Approved
• Source: shutterstock.com

The US Food and Drug Administration did not approve any original PMAs or panel-track PMA supplements during the week of 23 July to 29 July.

The FDA approved 17 non-panel track PMA supplements, including the approval of Intersect ENT Inc.’s Straight Delivery...

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

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By Elizabeth Orr

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.