Spinal cord stimulator with AI technology receives CE Mark certification

Natalia Elliot | November 13, 2024 | News story | Research and Development |  AI, EU, Nevro, Pain, spinal cord stimulation 

The HFC iQ, a personalised spinal cord stimulation (SCS) system developed by Nevro that leverages AI technology to manage chronic pain , has received CE Mark certification in Europe.

Following on from US Food and Drug Administration (FDA) in 2022, the HFX iQ has received CE mark certification. The CE mark signifies that the product being sold in the European Economic Area (EEA) have passed high-quality tests for safety, health and environmental protection standards. The HFX iQ utilises the data from the HFX Algorithm which contains information from 80,000 implanted patients. The data points collected by the algorithm reach over 20 million. The implanted device combines high-frequency therapy with these data points, and starts patients on a programme most likely to provide pain relief. Patients are able to customise their treatment options based on information they input on the HFX App.

Dr Ganesan Barnidharanm, anaesthesia and pain management consultant at Leeds Teaching Hospital NHS Trust, commented: “HFX iQ represents a transformative advancement in how we approach chronic pain management. By leveraging AI technology and data-driven programming – developed using over 10 years of outcomes and real-world patient data – HFX iQ has the potential to not only help optimise healthcare resources through reduced in-person programming and unnecessary hospital visits, but it also sets new standards for earlier and effective pain management along with patient engagement in spinal cord stimulation.”

Select European countries will be offered the HFX iQ system starting in 2025.

Natalia Elliot

13/11/24