MiRus Receives FDA 510(k) Clearance for GALILEO Spine Alignment Monitoring System

By Julie A. Vetalice

MiRus Receives FDA 510(k) Clearance for GALILEO Spine Alignment Monitoring System

MiRus was granted FDA 510(k) clearance to market the GALILEO™ Spine Alignment Monitoring System, a non-optical, wireless, real-time measurement system for segmental and global sagittal spine alignment.

GALILEO is reportedly the first FDA-cleared product that can intra-operatively measure sagittal plane alignment without the need for repeated imaging. MiRus plans to incorporate dynamic tracking and feedback into its robotics platform.

Source: MiRus, LLC

Product Labels: Surgical Navigation

Tags: 510(k) Clearance, Regulatory