Nevro Corp (Redwood City, California) has received approval from the FDA to begin offering what the company claims is the first spinal cord stimulation device that uses artificial intelligence to optimize and maintain pain relief for patients with chronic pain.

The company will initiate a limited release of the stimulator, the Senza HFX iQ, in the United States in late 2022, with a broad launch planned for early 2023. Nevro has also applied for approval in Europe.

The Senza HFX iQ system comprises an implantable pulse generator, a trial stimulator, a charger, and a smartphone app. The system will launch with algorithms specifically for treating chronic back and leg pain, including nonsurgical back pain and painful diabetic neuropathy. Nevro claims that it developed its algorithms using "20 million datapoints and 80,000 implanted patients."

The device is designed to optimize care by collecting patient data and guiding the patient through a customized treatment pathway, according to a press release posted by the company's public relations representative on the Associated Press website.

Patients can input information through the app, and can also adjust the pain relief through their smartphone app, without needing a separate remote control. The device captures information that can be shared with the treating physician and care team.

In the press release, D. Keith Grossman, Chairman and CEO of Nevro, said, "... Pain is variable from patient to patient and over time. Using the big data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programs where patients have been more likely to get relief in the real world. HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend program changes. ..."

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