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FDA Grants Breakthrough Device Designation to Scoliosis Progression Blood Test
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NEWS | INDUSTRY

FDA Grants Breakthrough Device Designation to Scoliosis Progression Blood Test .

Orthopedics This Week
/ Oct 5, 2026

Could a blood test help determine which adolescent scoliosis curves are most likely to progress? VB Spine announced FDA Breakthrough Device Designation for ScolimiR-3D, a microRNA-based blood test intended to stratify progression risk in adolescent idiopathic scoliosis. The assay measures 6 circulating microRNAs and could potentially support earlier bracing and more individualized surveillance. Breakthrough designation is not FDA approval, and prospective clinical validation will be important before routine adoption. 

Read the full News article from Orthopedics This Week
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How to cite this News

Orthopedics This Week. FDA Grants Breakthrough Device Designation to Scoliosis Progression Blood Test. 2026. Available from: https://orthotw.com/2026/09/vb-spine-announces-fda-breakthrough-device-designation-for-new-blood-test-designed-to-identify-patients-at-risk-for-scoliosis-progression?utm_source=chatgpt.com

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