APPROVALS

AI device to treat chronic pain approved by FDA

The FDA has approved the use of the Nevro Corporation’s advanced spinal cord stimulator (SCS), which uses AI to individualise treatment for the specific patient to treat their individual chronic pain.
Nevro’s Senza HFX iQ device is said to “learn from patients” as they continue to use the device, allowing it to create customised algorithms to treat the patient’s pain, specifically chronic back pain, leg pain and pain from diabetic neuropathy.
The algorithm is designed to gradually adjust pain management, after accounting for patient input and medical data, including factors such as pain scores, activity levels and pain medication use. The patient will also be able to adjust the pain management programmes through a smartphone app linked to the device. The surgically implanted SCSs are often considered the last resource in chronic pain management, for patients who do not respond to other pain management strategies. They emit low levels of electricity to reduce the intensity of the patient’s pain signals.
 Keith Grossman, Chair and CEO of Nevro, said in a news release: “HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalises care. […] 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 programmes 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 programme changes.”