Ortho Kinematics' back diagnostic device lands expanded clearance

August 16, 2013 by Sony Salzman

The FDA grants 510(k) clearance to Ortho Kinematics for its Vertebral Motion Analysis spinal imaging device to diagnose neck pain.

Ortho Kinematics' back diagnostic device lands expanded clearance

With a new 510(k) clearance from the FDA in hand, Ortho Kinematics can offer its Vertebral Motion Analysis spine diagnostic test to patients with neck problems.

VMA was cleared to diagnose instability in the back, but now orthopedic surgeons can use it to find the root cause of neck pain as well. The device uses an X-ray imaging technique called fluoroscopy to capture each vertebra of the spine as the patient is in motion.

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Austin, Texas-based Ortho Kinematics touts the Vertebral Motion Analysis device as a more accurate alternative to the current standard-of-care diagnostic for spine problems.

The system is available at a select number of spine surgery centers in the U.S., and the company plans on a large-scale commercialization push in 2014.

"For many lumbar patients, VMA testing has made the difference in getting the right diagnosis to successfully treat unrelenting, debilitating back pain," CEO Paul Gunnoe said in prepared remarks. "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."