US FDA clears Mazor Robotics’ Mazor X Align deformity correction software

The Mazor X system

Mazor Robotics has received US Food and Drug Administration (FDA) clearance for its Mazor X Align software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform.

Mazor X Align is the latest module to be added to the Mazor X proprietary Preoperative Analytics software suite, and is designed to enable surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan simulates an entire spine, which is intended to allow preoperative estimation of the impact of a planned surgical correction on the patient’s posture postoperatively, considering segmental range-of-motion and final alignment parameters.

Mazor X Align will be released to a selection of Mazor X customers in early May. This early release will be followed by a widespread release during the second half of 2017.