NuVasive gets FDA Approval for Pulse Spinal Surgical Automation Platform

July 31, 2018  Source: MassDevice 141

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The San Diego-based company NuVasive has announced US-FDA 510(k) clearance for its Pulse spinal surgical automation platform. The platform includes 2D and 3D navigation and smart imaging capabilities, with implemented surgical planning, neuromonitoring, patient-specific rod bending tech and radiation reduction.

Dr. Stephen Ryu of the Palo Alto Medical Foundation said, “Pulse seamlessly integrates multiple intraoperative technologies through an intuitive guided surgical workflow within a single device and footprint in the operating room. Unlike other newer surgical technologies, Pulse enhances the surgeon’s ability and can positively affect outcomes by providing a modular platform of useful intraoperative tools that do not disrupt familiar workflow. Additionally, Pulse provides enhanced support throughout each case be it a simple decompression all the way to complex deformity cases.”

The platform has been integrated with a 360-degree low-profile multiple high-resolution cameras that allow uninterrupted line-of-sight and optimized workflow.

VP Matt Link, the tech & strategy executive VP  of NuVasive announced, “With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customized 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.”

By Ddu
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