Alert detail

Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia

Policy ID: 2026-10907Specialty: Multi-specialtyAdded: 6/2/2026Effective: June 1, 2026federal rule

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What changed

Final Rule published 2026-06-01. The Food and Drug Administration (FDA) is classifying the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the real-time ultrasound anatomy visualization and labeling

Who’s affected: Multi-specialty billing teams · Effective: June 1, 2026

Primary source: View the official CMS/MAC document ↗

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