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January 14, 2025

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 13, 2025. To view listings for other dates, see CDRH New - News and Updates.

• Revoked Emergency Use Authorizations
  • Access SARS-CoV-2 IgG (Beckman Coulter, Inc.)
  • Access SARS-CoV-2 IgM (Beckman Coulter, Inc.)
  • Access SARS-CoV-2 IgG II (Beckman Coulter, Inc.)
• De Novo Decision Summary:
  • DEN230027 - NaviCam ProScan 
• Premarket Approval Application and Humanitarian Device Exemption Modular Review - Guidance for Industry and FDA Staff
• Class I Recall: Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care Impact
• Recalls, Corrections and Removals (Devices) (Updated)