NuVasive's Pulse platform for spine surgery received FDA 510(k) approval, and it is now available for sale.
Pulse is an integrated platform made to increase safety and efficiency in spine surgery, according to a July 30 news release. Clinical evidence shows the system has enabled surgeons to reduce operating room time by up to an hour, save nearly $5,000 per patient in hospital costs and reduced time under anesthesia and hospital stays. It also helps surgeons scale back radiation exposure and improves surgical navigation.
"The Pulse platform launch is an incredible milestone for NuVasive and will help lead the digital transformation of spine surgery," CEO J. Christopher Barry said. "Surgeons are now able to seamlessly work with various technologies to address more clinical challenges in surgery from a single platform — something they could not do before Pulse."
Pulse received a CE mark from the European Union in June.