NuVasive (NSDQ:NUVA) announced today that it received CE mark approval for its Pulse spinal surgical automation platform.
San Diego-based NuVasive touts its Pulse system as a first-of-its-kind technology designed to integrate radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring and spinal alignment tools into one platform.
According to a news release, Pulse is currently the only enabling technology platform capable of utilization in 100% of spine procedures and throughout the entire operating room workflow. The company said it increases safety, efficiency and procedural reproducibility while addressing several common clinical challenges in spine surgery.
With CE mark approval, NuVasive said clinical evaluations for Pulse are now underway across multiple countries throughout Europe. Pulse has held FDA approval in the U.S. since July 2018.
“The latest CE mark approval and clinical evaluations are key commercialization milestones for the Pulse platform and further our plan for an expanded global launch later this summer,” NuVasive EVP of global business units Massimo Calafiore said in the release. “There is a substantial opportunity for enabling technology adoption in spine surgery, and we are leveraging our expertise in proceduralization to introduce Pulse.
“This next generation of enabling technology has applications that can be utilized in every spine procedure.”