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

FDA Launches New Webpage Dedicated To AR And VR Medical Devices

 
• By Brian Bossetta

The US Food and Drug Administration has launched a new webpage dedicated to medical devices that incorporate augmented reality and virtual reality technologies. The agency has approved some 39 AR/VR devices.

AR/VR Medical Devices
• Source: Shutterstock

Medical devices featuring augmented reality (AR) and virtual reality (VR) have game-changing potential, according to the US Food and Drug Administration, which on 7 December launched a webpage dedicated to these devices.

The FDA says the page is intended to be a resource for the public about these innovative devices and the...

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 Regulation

Medical Device Recalls Down In Q1 For Lowest Quarterly Count In 3 Years. But Will It Last?

 
• By Brian Bossetta

Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.

23andMe Genetic Tests Among 12 New FDA Classifications

 
• By Elizabeth Orr

A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.

Why EU Innovators Face Growing Barriers With EU Combination Product Regulation

 
• By Amanda Maxwell

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

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.

More from Policy & Regulation

Medical Device Recalls Down In Q1 For Lowest Quarterly Count In 3 Years. But Will It Last?

 
• By Brian Bossetta

Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.

Dexcom Nabs Weight Management Indication For Signos CGM

 
• By Malcolm Spicer

Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.

German Health Researchers Prep for Possible Disruptions to PubMed, ClinicalTrials.gov

 
• By Elizabeth Orr and Francesca Bruce

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.