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

Global Device Approvals, Weekly Snapshot: April 9-15, 2018

 
• By David Filmore and Reed Miller

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approved

Seven novel device or indication approvals were added to Medtech Insight's Approvals Tracker last week, including actions in the US, Europe and Taiwan.

Among approvals in Europe, HeartStitch, Inc., and Nobles Medical Technology II, Inc., gained a CE mark for its Noblestitch minimally...

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

NeuroOne Prepares To Launch Trigeminal Nerve Ablation System

 
• By Elizabeth Orr

The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.

Nyxoah Launches FDA-Cleared Genio System For OSA As Rival Inspire Files Patent Suit

 
• By Marion Webb

After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 
• By Brian Bossetta

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

More from Policy & Regulation

Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters

 
• By Brian Bossetta

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.