MiRus Gains FDA Clearance for CYGNUS Anterior Cervical Plate

By Julie A. Vetalice

MiRus received FDA 510(k) clearance to market the CYGNUS™ Anterior Cervical Plate, reportedly the narrowest and thinnest cervical plate available.

CYGNUS' I-beam design and molybdenum alloy enable a smaller than usual footprint without sacrificing performance. The narrow profile is intended to require less retraction and anterior vertebral body preparation, resulting in shorter procedures and a minimized risk of complications such as dysphagia and dysphonia.

The company recently announced FDA clearance for 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: Spinal Fusion

Tags: 510(k) Clearance, Regulatory