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Business · 01/06/2026

FDA Classifies Real-Time Ultrasound Anatomy Visualization Device for Ultrasound Guided Regional Anesthesia into Class II

The FDA has classified the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia into Class II, a move aimed at ensuring the device's safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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