Ortho Kinematics said today it won Health Canada authorization for its Vertebral Motion Analysis spinal imaging system.
The VMA system from Austin, Texas-based Ortho Kinematics uses fluoroscopy to capture images of the spine in motion, is designed to displace traditional X-ray imaging as the primary method for identifying spinal dysfunction, the Austin, Texas-based company said.
The company said the system has been shown to increase sensitivity in detecting radiographic instability without a decrease in specificity in peer-reviewed studies.
“Expanding into Canada is a big step forward in positioning the VMA as a global standard of care for assessing spinal motion and instability. We believe Canadian patients and their providers stand to benefit significantly,” CEO Paul Gunnoe said in a prepared statement.
Ortho Kinematics said it plans to begin offering the VMA system in Canada later this year, with initial distribution limited to a select group of spine care institutions.
In April, Ortho Kinematics said it won CE Mark approval in the European Union for its Vertebral Motion Analysis system designed to assess spinal motion and radiographic instability.
The company said that prior to winning CE Mark approval, the device had won clearance from the FDA.
In January, Ortho Kinematics said it raised $4 million in a debt financing round to support the general biz and expand the commercialization of its flagship Vertebral Motion Analysis radiographic assessment device.
The round was led by early stage tech venture focused TEXO Ventures and joined by other previous investors, the company said.