Ortho Kinematics Inc. received CE mark approval for its Vertebral Motion Analysis product, which allows commercialization of the product in European markets, according to a company release.
Vertebral Motion Analysis (VMA), which is already cleared by the U.S. Food and Drug Administration, is a new test for the assessment of spinal motion and radiographic instability. Such testing for spinal motion and radiographic instability provides diagnostic data necessary for many patients who are being considered for spine surgery.
“The VMA technology has a multi-billion-dollar annual worldwide revenue potential, and with CE mark approval we can now expand our efforts toward realizing that potential,” Paul Gunnoe chief executive officer of Ortho Kinematics Inc., said in a company press release. “Europe is very attractive in that it represents the largest market for the VMA technology outside of the U.S.”
According to the release, VMA has been shown in peer-reviewed studies be more accurate, repeatable and result in a lower dose of radiation than current test methods.