NuVasive secures 510(k) clearance for Pulse surgical automation platform

31 July 2018 (Last Updated August 1st, 2018 06:31)

Spine technology provider NuVasive has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Pulse surgical automation platform.

Spine technology provider NuVasive has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Pulse surgical automation platform.

Serving as the foundation for Surgical Intelligence, the platform offers 2D- and 3D-navigation and smart imaging capabilities while integrating the firm’s neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies.

“This platform offers an intuitive surgeon experience by expecting user requirements and fusing these technologies to create a seamless, optimised workflow for operating rooms.”

As a single platform, it addresses a wide range of clinical challenges whilst offering improved utility and intuitive workflow.

The blend of these technologies is expected to support reproducible spine surgery at several health facilities and ambulatory surgery centres.

NuVasive executive vice president of strategy, technology and corporate development Matt Link said: “With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customised applications.

“Through the aggregation of clinical data and intelligent design, Pulse intuitively delivers the necessary technological intervention to drive improvements in procedural workflow and support the clinical needs for each OR, surgeon and case.”

The FDA approval for Pulse is seen as a major milestone in the company’s commitment to launch 2D- and 3D-navigation technologies built on the platform of its NVM5 nerve monitoring system, LessRay, Bendini and Integrated Global Alignment (iGA) systems.

Pulse integrates several high-resolution cameras along with 360-degree arrays to enable uninterrupted line-of-sight as well as optimise procedural workflow. This would inturn help surgeons to overcome frequent visualisation challenges they encounter during spine surgery.

Further, Pulse features advanced artificial intelligence (AI) due to automation of several technologies utilised throughout a surgical procedure.

This platform is claimed to offer an intuitive experience during surgical procedures by expecting user requirements and fusing several technologies to provide a seamless, optimised workflow in operating rooms.