Nevro Secures FDA Nod HFX iQ Spinal Cord Stimulation System For to Personalize Pain Treatment

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  • The FDA approved Nevro Corp's NVRO Senza HFX iQ spinal cord stimulation (SCS) system.
  • Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns from patients. 
  • The Senza HFX iQ system comprises the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator, Charger, and HFX App. 
  • Recommends customized therapy adjustments informed by patient inputs.
  • Also Read: Nevro Wins Multiple Coverage Options For Spinal Cord Stimulation In Diabetic Neuropathy.
  • It will launch with algorithms for treating chronic back and leg pain, including non-surgical back pain and painful diabetic neuropathy.
  • Senza HFX iQ is digitally-enabled and designed to optimize care by collecting patient data and guiding the patient through a customized treatment pathway. 
  • Directly adjusts the pain relief program on the patient's IPG from the HFX App on their smartphone without needing a separate manual remote.
  • Nevro will initiate a limited release of Senza HFX iQ in the U.S. this quarter, with a broad U.S. market launch planned for early 2023. In addition to the U.S. approval for HFX iQ, Nevro has submitted for approval in Europe.  
  • Price Action: NVRO shares are up 0.71% at $36.69 during the market session on the last check Thursday.
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