Bolt Achieves EU MDR Class IIb and ISO 13485 Certification

We're pleased to announce that the Bolt system has achieved EU MDR Class IIb and ISO 13485 certification. As one of the first Class IIb products certified under MDR, this milestone reflects the clinical evidence and quality systems behind Bolt.

Europe is a significant opportunity for Bolt as a cost-effective, image-guided navigation system that improves accuracy and efficiency while reducing radiation exposure. We look forward to launching in select EU countries in the coming weeks.