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Nevro receives FDA approval for Senza HFX iQ to treat chronic pain

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p >Nevro has received US Food and Drug Administration ( FDA ) approval for its Senza HFX iQ spinal cord stimulation ( SCS ) system to treat chronic pain . p >

p > The Senza HFX iQ SCS system has been developed for addressing the variability in pain from patient to patient and to optimise and maintain long – term pain relief , as well as improved life quality . p >

p > It includes the HFX Trial Stimulator , HFX App , HFX iQ Implantable Pulse Generator ( IPG ), and Charger . p >

p > The digitally enabled device will be introduced with algorithms that are specifically developed to treat chronic back and leg pain , along with non – surgical back pain , as well as painful diabetic neuropathy . p >

p > It is intended to optimise care by collecting the patients ‘ data and guiding them through a personalised treatment process . p >

p > Senza HFX iQ is claimed to be the first and only SCS system that uses Artificial Intelligence ( AI ) for optimising and maintaining pain relief using the response of a patient . p >

p >Nevro chairman and CEO D Keith Grossman said : “ HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalises care . p >

p >“ HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend programme changes . p >

p >“ HFX iQ utilises our superior high – frequency 10 kHz Therapy platform , which has been proven in clinical trials and is further supported by real – world evidence from more than 90 , 000 implanted patients .” p >

p > The company noted that Senza HFX iQ offers several advantages over other SCS systems . p >

p > It recommends customised therapy adjustments based on patient inputs on the HFX App , which include pain score , pain relief percentage , change in activity levels , and pain medications . p >

p > Senza HFX iQ can directly adjust the pain relief programme on the IPG of a patient , through the HFX App , without requiring a separate manual remote . p >

p > The system gathers patient and device data for sharing patient – level outcomes with treating and referring physicians , and also offers a connected , digital environment around a patient ‘ s therapy . p >

p >Nevro intends to release the Senza HFX iQ system at limited scale in the US this quarter and has plans to launch across the nation early next year . p >

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