FDAnews
www.fdanews.com/articles/181327-fda-awards-marketing-clearance-to-mazor-robotics-spinal-deformity-correction-planning-software

FDA Awards Marketing Clearance to Mazor Robotics’ Spinal Deformity Correction Planning Software

April 12, 2017

Mazor Robotics has received FDA clearance for its Mazor X Align software.

The product is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X surgical assurance platform.

The device software extends the company’s proprietary pre-operative analytics software suite which enables surgeons to create a patient-specific, three-dimensional spinal alignment plan.

The 3D plan simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, 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, with widespread release in the second half of 2017. — Cynthia Jessup

View today's stories