Ortho Kinematics Receives CE Mark for Vertebral Motion Analysis

By Julie A. Vetalice

Ortho Kinematics received CE Mark approval for its Vertebral Motion Analysis (VMA) technology. Commercialization will begin in the U.K. during 2016.

The diagnostic VMA test assesses spinal motion and radiographic instability in patients being considered for spine surgery. In peer-reviewed studies, VMA has been shown to increase sensitivity in detecting radiographic instability with no decrease in specificity relative to the current standard testing method. It has also been shown to be more accurate, repeatable and result in a lower dose of radiation.

Source: Ortho Kinematics, Inc.

The first iteration of VMA received FDA 510(k) clearance in 2011, followed by expanded indications in 2012 and 2013. In 2014, the company partnered with Medtronic to promote VMA's use to spine surgeons.

Tags: CE Mark, Regulatory