NuVasive Gains FDA Clearance for Pulse Surgical Automation

By Julie A. Vetalice

NuVasive received FDA 510(k) clearance to market Pulse™ surgical automation, the foundation for the company's Surgical Intelligence™ system.

Pulse introduces the 2D and 3D navigation component and smart imaging capabilities, and integrates neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies. It can be used at all facilities, from major health systems to ambulatory surgery centers.

NuVasive's Surgical Intelligence Platform comprises six phases that will integrate neuromonitoring, surgical planning, radiation reduction, navigation/imaging, cloud integration/data connectivity and data insights/smart tools to optimize the O.R.

Source: NuVasive, Inc.

Product Labels: Surgical Navigation, Surgical Planning

Tags: 510(k) Clearance, Regulatory