Business · 06/10/2026Updated: 10/17/2026 · 1 min read
FDA Classifies Focused Ultrasound System for Non-Thermal Tissue Ablation
Summary
The FDA has classified the focused ultrasound system for non-thermal, mechanical tissue ablation into Class II, requiring special controls to ensure safe and effective use.
Original source language: Federal Register — Health and Human ServicesOpen original release →