NuVasive's Pulse gets nod from EU, begins clinical evaluations in Europe

Spinal Tech

NuVasive's spine imaging platform, Pulse, received a CE mark of approval from the European Union, the spine device company said June 30.

Along with the CE mark, NuVasive started clinical evaluations of Pulse in several European countries. Pulse integrates radiation reduction, rod bending, navigation, intraoperative neuromonitoring and spinal alignment into one platform. It can be used in all spine procedures.

"There is a substantial opportunity for enabling technology adoption in spine surgery, and we are leveraging our expertise in proceduralization to introduce Pulse," Massimo Calafiore, executive vice president of global business, said. "This next generation of enabling technology has applications that can be utilized in every spine procedure."

NuVasive submitted an application for FDA approval in February. The company plans to feature Pulse at two conferences in July.

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