Guidance Outlines Testing Parameters For MRI-Compatible Devices

The new document details how companies can test passive medical devices, such as orthopedic implants and stents, against risks from radiofrequency-induced heating during an MRI scan.

FDA has finalized a guidance that tells device manufactures how they can evaluate whether multi-configuration, passive medical devices are compatible with MRI scanners.

Implanted medical devices, including orthopedic implants and cardiovascular stents, are often made of electrically conductive materials and configured in a...

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 Clinical Trials

SS Innovations’ SSI Mantra 3 Poised To Challenge Da Vinci In Robotic Surgery Market

 
• By Marion Webb

SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 
• By Natasha Barrow

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 
• By Natasha Barrow

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

 
• By Marion Webb, Brian Bossetta, Natasha Barrow, Elizabeth Orr, and Shubham Singh

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

More from R&D

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 
• By Natasha Barrow

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.

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.