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adsilico raises 10 million pounds to test implants on virtual patients X9 wins a Breakthrough designation for power-assisted dialysis cannulation Smith+Nephew and J&J ortho merger talks collapse over who would run it Rivanna clears a machine learning bone overlay for its Accuro XV ultrasound Teleflex takes a Breakthrough designation for its resorbable magnesium scaffold in PCI Edwards wins FDA approval for Pascal Precision in tricuspid repair EQT agrees to take Qiagen private for 10.8 billion euros Elucid clears FFR-IQ under K262015 and folds plaque biology into FFR-CT Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans adsilico raises 10 million pounds to test implants on virtual patients X9 wins a Breakthrough designation for power-assisted dialysis cannulation Smith+Nephew and J&J ortho merger talks collapse over who would run it Rivanna clears a machine learning bone overlay for its Accuro XV ultrasound Teleflex takes a Breakthrough designation for its resorbable magnesium scaffold in PCI Edwards wins FDA approval for Pascal Precision in tricuspid repair EQT agrees to take Qiagen private for 10.8 billion euros Elucid clears FFR-IQ under K262015 and folds plaque biology into FFR-CT Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans

510(k)

Rivanna clears a machine learning bone overlay for its Accuro XV ultrasound

MedDevice Startups Staff · 5 days ago · 2 min read · Via BioSpace

Rivanna Medical cleared BoneEnhance, a machine learning module for its Accuro XV ultrasound system. The Charlottesville, Virginia company announced the 510(k) on October 22. It is the first machine learning layer on the platform.

BoneEnhance segments bone and surrounding tissue in the volumetric scan data, then paints color-coded overlays on the 2D B-mode image. The underlying anatomy stays visible beneath the overlay. A 3D indicator shows scan orientation and slice location during review.

Rivanna's injury detection module is investigational and sits outside this clearance. The company develops the platform under HHS, ASPR and BARDA contract 75A50121C00035, and says it holds more than 100 issued and pending patents. Will Mauldin is co-founder and CEO.

Questions & Answers

What is Rivanna Medical's BoneEnhance?

BoneEnhance is a machine learning software module for the Rivanna Medical Accuro XV ultrasound system. It segments bone and surrounding tissue in volumetric scan data and displays color-coded overlays on the 2D B-mode image while leaving the underlying anatomy visible.

When did Rivanna Medical clear BoneEnhance?

Rivanna Medical announced the BoneEnhance 510(k) clearance on October 22, 2026. It is the first machine learning layer cleared on the Accuro XV platform.

Is Rivanna's injury detection module part of the BoneEnhance clearance?

No. Rivanna Medical's injury detection module remains investigational and sits outside the BoneEnhance 510(k) clearance.

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