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FDA Updates

Published: 07/09/2024

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities:

  • Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions 
  • Philips North America LLC. Updates Use Instructions for SENSE XL Torso (1.5T And 3.0T) Coils Due to a Potential Issue Where the Coil Heats Up During MRI Scans, Possibly Leading to Thermal Injury 
  • FDA Issues Revised Draft Guidance on…

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