Congratulations to NORTION on FDA Breakthrough Device Designation for Composite Steep Pulse Therapy Device
The FDA Breakthrough Device Designation is an expedited pathway established by the U.S. Food and Drug Administration to accelerate the development of medical devices with breakthrough technologies.
NORTION's receipt of the FDA Breakthrough Device Designation (BDD) for its Composite Steep Pulse Therapy Device demonstrates the technology's cutting-edge innovation and exceptional clinical value. This achievement grants access to the U.S. innovation market with expedited review privileges, solidifying NORTION's leadership in technological R&D and enhancing its global competitiveness. It paves the way for future clinical applications and commercialization – a highly prestigious recognition that powerfully validates NORTION's innovative capabilities.