Ortho Kinematics, an Austin, Texas-based healthcare diagnostics company focused on spine imaging informatics, received ISO 13485:2003 certification.
Here are five key notes:
1. The certification is a quality standard for medical devices.
2. Also, the FDA completed a Level I inspection of Ortho Kinematics' facilities, resulting in the company clearing the audit.
3. Ortho Kinematics' main product, VMA, is a diagnostic test for spinal motion and radiographic instability.
4. The company more than tripled the VMA's install base in the last six months.
5. VMA is designed to provide more accuracy and requires a lower radiation dose.