Medical Device Network

Nevro secures CE mark for AI-based spinal cord stimulation system

The CE marking enables the company to market its spinal cord stimulation system across the EU following a US approval in 2022.

US-based device company Nevro has secured market authorisation from the European Union (EU) for its HFX iQ spinal cord stimulation (SCS) system.

The HFX iQ is an advanced SCS system designed to help manage chronic pain by using artificial intelligence (AI) and high-frequency therapy. The system gathers real-time data from patients through a smartphone app, allowing it to adjust treatment based on each patient’s pain levels, activity, and medication use.

Designed for various pain conditions, HFX iQ uses specialised algorithms based on extensive clinical data to tailor therapy for individual needs. With dual-frequency capability, Bluetooth enabled adjustments, and cloud connectivity, it delivers responsive, customisable pain management without the need for additional surgeries.

The CE mark allows Nevro to expand into the EU market, after gaining clearance from the US Food and Drug Administration (FDA) in 2022. Nevro plans to offer the HFX iQ system in select European countries starting in Q1 2025.

The market authorisation reflects an industry trend towards more personalised, AI-driven, data-based patient care. According to a report on GlobalData’s Medical Intelligence Center, the AI in medical market is forecast to be worth $1.2bn by 2027, growing at a compound annual growth rate (CAGR) of 29.1% from $336m in 2022.

Dr Ganesan Baranidharan, anaesthesia and pain management consultant at Leeds Teaching Hospital NHS Trust said: “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.”

In December 2023, Nevro struck a deal worth $75m with devicecompany Vyrsa Technologies. Founded in 2021, Vyrsa specialises in in minimally invasive treatments for chronic sacroiliac joint pain. As part of a restructuring effort, California-based Nevro reduced its workforce by 63 employees (5%) in January 2024, announcing layoffs alongside fourth quarter 2023 results that showed a 2% year-over-year revenue growth to approximately $116m.

Nevro is not the only player in the space using AI for pain management. A June 2024 real-world study of NXTSTIM’s FDA-approved AI wearable nerve stimulation device found that 92% of patients reported pain improvement over 18 months.