Nevro gets FDA approval for HFX AdaptivAI, a self-adjusting spinal cord stimulator

Globus Medical/Nevro HFX (10 kHz spinal cord stimulation)

Nevro announced FDA approval and a limited US release of HFX AdaptivAI, software that adjusts stimulation using patients' own reports plus data from more than 100,000 patients. It keeps tuning therapy even after a patient passes 50% pain relief, and power management lets some patients recharge as rarely as six times a year. A full US launch was planned for the fourth quarter of 2024.

• Built on more than 100 million data points from 100,000+ patients.
• Charging as infrequently as six times a year.
• Limited release on approval; full US launch in Q4 2024.