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Spinal Frontiers · Regulatory Watch · FDA decision

FDA clears AI tool that flags low bone density on routine spine X-rays

FDA decision · Naitive Technologies (UK)

27 October 2026

OsteoSight Spine analyses standard frontal lumbar, thoracic or chest radiographs in patients aged 50 and over and alerts the reporting doctor to possible low L1–L4 bone mineral density, prompting a bone health work-up. It does not replace DXA and a missing report does not rule out low bone density.

Type
FDA decision
Company
Naitive Technologies (UK)
Device
OsteoSight Spine (v1)
Date
27 October 2026
Jurisdiction
US
Classification
510(k) K261512 (SAO)
Source
FDA 510(k) database

Official source →Source checked

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