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Nevro HF10 therapy receives FDA approval for painful diabetic neuropathy — first SCS for this indication

Nevro Press Release3/23/2026·03/23/26🌐 USA

Summary

Nevro received FDA approval for HF10 spinal cord stimulation for painful diabetic neuropathy, becoming the first SCS therapy approved for this indication. The SENZA-PDN pivotal trial demonstrated 76% of patients achieving 50% or greater pain relief at 3 months versus 6% for conventional medical management.

Why it matters

Painful diabetic neuropathy affects 26% of the 37 million US diabetics — approximately 9.6 million patients — making this the largest new SCS indication in history. With a 76% vs 6% responder rate versus medical management, HF10 PDN approval will create a major new market segment.

#BCI#Chronic Pain#FDA#Spinal Cord Stimulation

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