Ortho Kinematics (OKI) has received CE mark approval for its lead product, Vertebral Motion Analysis “VMA”.
Prior to securing CE mark approval, the VMA had regulatory clearance from the US Food and Drug Administration (FDA) to commercialise in the United States. With this additional approval, OKI can begin selling the VMA technology in EU Countries.
VMA, or Vertebral Motion Analysis, is a diagnostic test designed for the assessment of spinal motion and radiographic instability. The VMA has been shown in peer-reviewed studies to increase the sensitivity in detecting radiographic instability with no decrease in specificity relative to today’s current standard test. It has also been shown to be more accurate, repeatable, and result in a lower dose of radiation.
OKI intends to begin commercialization efforts later this year in the UK, expanding from there.
