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Breakthrough designation for blood test predicting scoliosis progression

FDA decision · VB Spine

29 September 2026

VB Spine announced FDA Breakthrough Device Designation for a six-microRNA blood test, developed at CHU Sainte-Justine, that aims to estimate which AIS patients are at risk of severe curve progression. Validation so far rests on a small 116-patient study.

Type
FDA decision
Company
VB Spine
Device
ScolimiR-3D blood test for adolescent idiopathic scoliosis
Date
29 September 2026
Jurisdiction
US
Classification
Breakthrough Device Designation
Source
SPINEMarketGroup (company announcement)

Official source →Source checked

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