NuVasive wins FDA nod for Pulse spinal surgical automation platform

NuVasive (NSDQ:NUVA) said today it won FDA 510(k) clearance for its Pulse spinal surgical automation platform.

The newly cleared Pulse system includes both 2D and 3D navigation and smart imaging capabilities with integrated neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending tech, the San Diego-based company 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,” Dr. Stephen Ryu of the Palo Alto Medical Foundation said in a prepared statement.

The platform has multiple integrated high-resolution cameras and a low-profile, 360-degree array intended to allow for uninterrupted line-of-sight and optimized procedural workflow, NuVasive said.

“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,” NuVasive corp dev, tech & strategy exec VP Matt Link said in a press release.

Last week, NuVasive said it launched its Reline MAS midline system designed to treat adjacent segment transition syndrome.

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