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Home » Nevro wins FDA nod for AI-driven spinal cord stimulation tech

Nevro wins FDA nod for AI-driven spinal cord stimulation tech

September 24, 2024 By Sean Whooley

Nevro HFX AdaptivAI HFX iQ (1)
HFX AdaptivAI powers HFX iQ. [Image courtesy of Nevro]
Nevro (NYSE:NVRO) announced today that it received FDA approval for an AI-powered, personalized pain management platform for spinal cord stimulation.

HFX AdaptivAI, a responsive, personalized pain management platform, powers the HFX iQ spinal cord stimulation (SCS) system. The Redwood City, California-based company kicked off a limited market release of the offering following this approval.  It originally launched the HFX iQ system in March 2023.

The company plans for a full market release in the U.S. in the fourth quarter of 2024.

Nevro says its HFX AdaptivAI is the only technology with AI for providing patients suffering from chronic pain with “an unprecedented level of personalized, responsive pain relief.”

The launch comes at a time of uncertainty for Nevro, which last month said it began looking into strategic alternatives amid increased competition in the SCS market.

“Nevro is further establishing its position as the leading developer of data-driven solutions for pain management through the launch of HFX iQ with HFX AdaptivAI,” said Kevin Thornal, Nevro’s CEO and president. “HFX AdaptivAI delivers personalized pain relief, utilizing AI and leveraging millions of data points and ten years of innovation and patient care. We believe this new solution is a major milestone, and it demonstrates our dedication to freeing patients from the burden of chronic pain through evidence-based therapies that transform patients’ lives.

“Importantly, HFX AdaptivAI puts patients in control of their pain relief while, at the same time, providing physicians the ability to monitor their patient’s pain journey – closing the loop that matters.”

More about the Nevro HFX AdaptivAI offering

Features of HFX AdaptivAI include maximized pain relief. Nevro says the system continues to optimize therapy even when users achieve pain relief over 50%.

The system has Bipole Interlacing, a proprietary technology that creates customized therapy in real-time using direct patient input. HFX AdaptivAI also has smart power technology, optimizing therapy while allowing patients to charge their device as infrequently as six times per year.

Nevro designed the system to provide enhanced real-time insights, with the AI gathering real-time quality of life (QoL) metrics and device data. This enables more impactful patient-clinician interactions. The real-time information helps patients report pain relief in significantly less time than with traditional programming, too.

Additionally, with the launch, physicians can remotely monitor their patients’ pain journey through the Nevro healthcare provider portal.

“Chronic pain is a dynamic, biopsychosocial human condition unique to each individual,” said Dr. David Caraway, Nevro’s chief medical officer. “To effectively treat suffering — as perceived by each patient — therapies must be personalized based on the changing experience of pain. Only HFX AdaptivAI seeks to engage with the patient and personalize the SCS therapy in real time using evidence based on algorithms and multi-dimensional metrics of pain relief, function and satisfaction.”

Filed Under: Artificial Intelligence (AI), Business/Financial News, Featured, Food & Drug Administration (FDA), Health Technology, Machine Learning (ML), Neurological, Neuromodulation/Neurostimulation, Pain Management, Regulatory/Compliance, Software / IT Tagged With: Nevro Corp.

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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