Zdrowie i gospodarka · 10/09/2026

FDA Classifies Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures into Class II (Special Controls)

The FDA has classified the temperature regulation device for esophageal protection during cardiac ablation procedures into Class II, a category that requires special controls to ensure the device's safety and effectiveness, aiming to enhance patients' access to innovative devices while reducing regulatory burdens.