Treatment follows recent Food and Drug Administration approval of the SetPoint System for treatment of RA, a bioelectronic medicine breakthrough

Northwell Health and SetPoint Medical today announced that Northwell is the first health system to provide the recent U.S. Food and Drug Administration (FDA)-approved SetPoint^® System to patients showing their commitment to expand patient access to bioelectronic medicine treatment for rheumatoid arthritis (RA).

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Northwell is first to implant patient with FDA-approved SetPoint System bioelectronic medicine device (Credit: SetPoint).

The first patient to receive the FDA-approved device was surgically implanted on August 22 at Northwell’s North Shore University Hospital. The patient will receive post-surgical follow-up care in the coming weeks, at which time the device will be activated. The FDA approved the SetPoint System on July 30, offering a novel, non-pharmaceutical treatment option for adults living with moderate-to-severe RA who are not adequately managed by—or cannot tolerate—existing advanced RA therapies, such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).

“Northwell Health is committed to providing patients with the most scientifically-backed, innovative and effective treatment options available,” said Michael J. Dowling, president and CEO of Northwell. “Our collaboration with SetPoint Medical reinforces this commitment by offering a groundbreaking new approach for managing rheumatoid arthritis, a condition that significantly impacts millions of lives.”

This FDA approval validates nearly three decades of pioneering research led by Kevin J. Tracey, MD, president and CEO of Northwell’s Feinstein Institutes for Medical Research and the Karches Family Distinguished Chair in Medical Research, and his team, who have been exploring the intricate links between the brain, immune system, inflammation and the therapeutic potential of modulating these pathways, specifically through the vagus nerve. Northwell’s newly established Center for Bioelectronic Medicine, located at 350 Community Drive in Manhasset, NY, offers patients access to cutting-edge clinical trials and FDA-approved treatments including the SetPoint System. The Center, spearheaded by the Northwell medicine and neurosurgery service lines, underscores its leadership position in the field and allows Northwell to begin offering this novel therapeutic approach to RA patients.

“Bioelectronic medicine represents a profound shift in the future of healthcare, and Northwell is proud to be leading this transformation,” said John D’Angelo, CEO-Elect of Northwell. “With a relentless focus on innovation, our team is advancing breakthrough technologies that will redefine how disease is understood, treated, and prevented.”

The collaboration will leverage SetPoint Medical’s FDA-approved device, which utilizes an integrated neurostimulator to modulate the body’s immune response (inflammation) and alleviate painful RA symptoms without immune-compromising risks. Northwell participated in the RESET-RA study, which evaluated the efficacy and safety of the SetPoint System, and demonstrated the potential of this therapy to provide relief for patients.

Dr. Tracey’s early groundbreaking work has illuminated the intricate connection between the nervous system and the immune system, called the “inflammatory reflex,” paving the way for new device-based therapies. Over time, and in line with anticipated future FDA approvals, Northwell will strategically expand the therapeutic applications of bioelectronic medicine for various conditions across relevant service lines, fostering education and knowledge sharing among providers.

Northwell Direct, Northwell Health’s direct-to-employer subsidiary, will provide access to the device and procedures through the Northwell Direct Network for qualified patients. Northwell Direct offers comprehensive health benefit solutions to employers and unions, including a high-performing network, care management services, and access to cutting-edge clinical innovations like SetPoint, all focused on quality and cost savings for the employers and members served. Northwell Direct’s provider network is provided through Northwell Direct Administrative Services Organization, Inc.

If you are interested in learning more about bioelectronic medicine and treatment with SetPoint’s device, call 1-227-BIO-INST (246-4678).

About Northwell Health

Northwell is the largest not-for-profit health system in the Northeast, serving residents of New York and Connecticut with 28 hospitals, more than 1,000 outpatient facilities, 22,000 nurses and over 20,000 physicians. Northwell cares for more than three million people annually in the New York metro area, including Long Island, the Hudson Valley, western Connecticut and beyond, thanks to philanthropic support from our communities. Northwell is New York State’s largest private employer with over 104,000 employees – including members of Northwell Health Physician Partners and Nuvance Health Medical Practices – who are working to change health care for the better. Northwell, named a TIME100 Most Influential Companies 2025, is making breakthroughs in medicine at the Feinstein Institutes for Medical Research. Northwell is training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies. For information on our more than 100 medical specialties, visit Northwell.edu and follow us @NorthwellHealth on Facebook, X, Instagram and LinkedIn.

About SetPoint Medical

SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases. The company’s FDA-approved SetPoint System is the first neuroimmune modulation therapy available for people living with rheumatoid arthritis (RA), offering a novel, device-based alternative for those who do not respond to or cannot tolerate biologic or targeted drug therapies. SetPoint’s proprietary integrated neurostimulation platform is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint. With a vision to redefine the care of autoimmune conditions, SetPoint is also planning to evaluate its platform technology for other conditions including multiple sclerosis and Crohn’s disease. Learn more at setpointmedical.com.

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