BoneEnhance (RIVANNA Accuro XV): FDA status

Approved Approved Oct 22, 2026. Indication: bone anatomy visualization during handheld point of care ultrasound.

Regulatory history

• Oct 22, 2026: 510(k) clearance. FDA granted 510k clearance for BoneEnhance, a machine learning overlay improving bone visualization on the Accuro XV handheld ultrasound platform. Morningstar

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