Nevro nabs FDA approval for spinal cord stimulator that uses AI to personalize pain treatment

Most neurostimulation devices can be manually adjusted by users and their caregivers to customize treatments for chronic pain, epilepsy, stroke recovery and more, but an implant newly approved by the FDA outsources some of those tweaks to artificial intelligence.

The Senza HFX iQ spinal cord stimulation system from Nevro continually assesses patients’ responses to its neurostimulation treatment for chronic pain then automatically recommends adjustments that may improve the efficacy of that treatment.

With freshly minted approval from the FDA—which Nevro announced this week—the system will begin a limited U.S. rollout by the end of the year, equipped with algorithms to treat chronic back and leg pain, including cases of nonsurgical back pain and painful diabetic neuropathy.

The company plans to further expand its reach across the country early next year while also continuing to pursue CE mark approval of the spinal cord stimulator in Europe.

The Senza HFX iQ system is made up of the implanted neurostimulator device as well as a trialing device to test the effects of neurostimulation for about a week before implantation, a charger and an accompanying smartphone app.

The system’s built-in algorithm suggests an initial therapy program that it has calculated as being the most potentially effective. Over time, it recalculates a patient’s individual neurostimulation dosage based on their inputs on the app, including perceived pain relief and pain score, as well as any changes in their activity levels or pain medications.

The AI algorithm was trained using real-world patient data, spanning more than 20 million data points collected from 80,000 patients.

“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,” said D. Keith Grossman, Nevro’s CEO. “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.”

If the algorithm’s recommended changes are accepted, the neurostimulation therapy can be adjusted directly from the app, without requiring a separate controller.

That therapy consists of mild electrical pulses that are sent from Nevro’s high-frequency stimulator to electrodes placed near the spinal cord. The pulses are meant to interrupt signals sent from the nervous system to the brain, calming the nerves and therefore reducing the feeling of pain.