Federal Register: FDA Streamlines Regulatory Pathway for Devices Preventing Esophageal Injury in Heart Surgeries
September 10, 2026
September 10, 2026
WASHINGTON, Sept. 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation . . .
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Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation . . .