Philips Launches AI-enabled MR Portfolio of Smart Diagnostic Systems

Royal Philips has announced new AI-enabled innovations in MR imaging launching at the Radiological Society of North America (RSNA) annual meeting. Philips’ new MR portfolio of intelligent integrated solutions is designed to speed up MR exams, streamline workflows,...

RSNA 2021 Expects Nearly 20,000 Attendees in Chicago

The Radiological Society of North America (RSNA) today announced that more than 19,000 attendees are registered to attend the Society’s 107th Scientific Assembly and Annual Meeting (RSNA 2021) at McCormick Place in Chicago (Nov. 28-Dec. 2), with another 4,000...

Hyland Healthcare to Demo Enterprise Imaging Solutions at RSNA

Hyland Healthcare will detail the company's robust enterprise imaging solutions at RSNA 2021. Hyland Healthcare continues to research and innovate in the space as to meet demands from its health care customers, as systems grow and data becomes more ubiquitous. As data...

Konica Minolta Healthcare Releases New Devices

Konica Minolta Healthcare Americas, Inc., announces the launch of the mKDR Xpress Mobile X-ray System and the AeroDR Carbon Flat Panel Detector, two solutions that are powerful alone yet extraordinary when used together. These new solutions reaffirm Konica Minolta’s...

FDA Issues Final Guidance on Medical Devices in the MR Environment


Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. This guidance document provides the FDA’s recommendations on testing to assess the safety and compatibility of medical devices in the MR Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. Ensuring the safety of patients who use magnetic resonance imaging (MRI) for disease diagnosis and health management is vital.

Read the Guidance »

Facts about the final guidance

This final guidance:

  • Provides recommended format to clarify and simplify labeling for magnetic resonance imaging (MRI) safety information consistent with FDA-recognized consensus standards.
  • Applies to all medical devices that might be used in the MR environment, including all implanted medical devices and all medical devices that are fastened to or carried by a patient (such as, external insulin pump or pulse oximeter). Note: the guidance does not apply to the MR system or accessories, such as MR coils and positioning pads.
  • Provides recommendations on MR safety and compatibility assessments and labeling information that should be included in premarket submissions.

Upcoming webinar on this guidance

On June 24, 2021, the FDA will host a webinar for industry and others interested in learning more about the guidance.



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