FDA Grants Breakthrough Device Designation to Scoliosis Progression Blood Test .

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.