Zdrowie i gospodarka · 10/09/2026

FDA Classifies Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures into Class II

The FDA is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into Class II, which will provide a reasonable assurance of the device's safety and effectiveness, and reduce regulatory burdens, thereby enhancing patients' access to innovative devices.