FDA Clears Machine Learning Module for Emerging Musculoskeletal Ultrasound Platform

The Food and Drug Administration (FDA) has granted 510(k) clearance for BoneEnhance, a machine learning module that provides automated segmentation for bone and surrounding tissue analysis with the Accuro XV ultrasound device.

The BoneEnhance feature bolsters 3D visualization of skeletal anatomy with the use of color-coded overlays on two-dimensional B-mode images acquired with the musculoskeletal ultrasound system, according to Rivanna, the manufacturer of the Accuro XV ultrasound platform, which received FDA clearance earlier this year.

The company pointed out that independent testing of the BoneEnhance module, involving 69,900 images from 173 patients, revealed a per-volume label prediction accuracy ranging from 95.1 to 100 percent.

“We founded Rivanna to solve a problem that cuts across care settings: decision-critical information sits outside the point-of-care workflow,” said Will Mauldin, PhD, Co-founder and CEO of Rivanna. “BoneEnhance is where the stack begins to close that gap for musculoskeletal care: automated volumetric acquisition, now paired with cleared software-assisted review. This clearance is the foundation: the first machine learning layer, anchoring the decision-support capabilities now in development.”