Ortho Kinematics has obtained the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VMA (Vertebral Motion Analysis) system to assess cervical spine (neck) in addition to lumbar spine.
This new diagnostic technology provides an alternative for the routinely prescribed tests for the assessment of spinal instability.
The VMA system uses fluoroscopy to capture the spine motion and produces patient-specific graphs for each vertebral level.
Ortho Kinematics CEO Paul Gunnoe noted for many lumbar patients, VMA testing has made the difference in getting the right diagnosis to successfully treat unrelenting, debilitating back pain.
"With the clearance of the cervical VMA system, we are very happy to now offer this same opportunity to patients with neck problems as well," Gunnoe added.
The clinical results also depicted its ability to identify difficult to detect spinal instabilities.
VMA testing also helps physicians to identify common and treatable pathology that may be difficult to detect with the currently available methods.
Dr David Lee, a spine surgeon user of the VMA lumbar system noted the VMA has been the only test capable of providing the evidence demanded by insurance companies to approve coverage for lumbar surgery.
"With the new cervical system, I can now offer this valuable option to my neck pain patients as well," Dr Lee added.
The company expects the full nationwide launch of VMA system in early 2014.