FDA Clears MiRus’ Spine Alignment Monitoring System
MiRus’ Galileo Spine Alignment Monitoring System has received 510(k) clearance from the FDA for spinal alignment.
The wireless, non-optical device is a real-time measurement system used in segmental and global sagittal spine alignment. It provides surgeons with feedback as they perform corrective procedures in the operating room and confirms that the alignment was successful.
According to the company, the device is the first product approved by the FDA that measures sagittal plane alignment in real-time without the heavy use of repeated imaging.