Spine device company NuVasive submitted its Pulse system and associated robotics application for approval in February.
Six things to know:
1. NuVasive said it hopes to achieve FDA clearance soon and launch the system in the summer.
2. Pulse is an open-imaging platform integrated with Siemens' 3D mobile C-arm, Cios Spine.
3. The system is expected to have applications for all spinal surgeries, not just complex or low-acuity cases.
4. Pulse features neuromonitoring, surgical planning, radiation reduction and rod-bending technologies, as well as imaging and navigation functions.
5. The timeline for the device had been delayed because of "software and hardware updates following beta testing, as well as the impact of COVID-19," CEO Chris Barry said.
6. NuVasive said it expects Pulse to compete with other robotic spine offerings on the market, including Medtronic's Mazor X, Globus Medical's Excelsius GPS and Zimmer Biomet's Rosa Spine.