Navigating medical apps and technology

Neurosurgeon Kevin J. Tracey, MD, has been trying to resolve rheumatoid arthritis and other damaging autoimmune disorders for 27 years, while always looking for a breakthrough in rheumatoid arthritis treatment.

Like lupus, Crohn’s disease and ulcerative colitis, RA is an intensely painful autoimmune disease in which the body overreacts to inflammation. RA gnaws at the joints of hands, wrists and feet, creating unsightly knobs while stoking inflammation, heat and pain.

Tracey sought a surgical alternative to traditional pharmaceutical therapies, “which use very powerful immunosuppressing drugs,” he says. “They’re not effective in many patients, and they have dangerous side effects. They have to be injected, and they’re extremely expensive.” 

As president and CEO of the Feinstein Institutes for Medical Research at Northwell Health and North Shore University Hospital, Tracey was obsessive—and came up with a concept for a bioelectronic gadget that he drew for a colleague on a napkin at lunch.

“I was explaining how you could turn off inflammation by stimulating the left vagus nerve,” he says. That approach was the key to success.

The role of the vagus nerve

As the body’s longest cranial nerves, the left and right vagus nerves are a communication highway between the brain and major organs. Tracey focused on the left vagus nerve. 

Like a Nest Cam, the left vagus alerts the spleen to the body’s version of package snatchers: infections, inflammation and tissue damage. 

But sometimes, the brain and immune system’s clear communication is disrupted. This allows chronic inflammation and chronic diseases such as rheumatoid arthritis, inflammatory bowel syndrome, Crohn’s disease and other autoimmune disorders to take hold.

Tracey’s idea became the SetPoint System, an implant that functions much like a neural pacemaker. When stimulated, it sends electrical pulses to steady and curb excessive long-term inflammation. 

SetPoint’s task is to target immunomodulating pathways in the vagus nerve. Thus, the spleen’s white blood cells slow the production of pro-inflammatory molecules to thwart inflammation, says Daniel Peterson, MD, principal neurosurgeon with Austin Neurosurgeons in Texas.

The size of a Tylenol capsule, the device sits on the left vagus nerve near the Adam’s apple. Neurosurgeons place it in an outpatient procedure that takes about an hour plus time to recover from anesthesia, says David Chernoff, MD, chief medical officer at SetPoint Medical. 

Once daily, the device stimulates the nerve for 1 minute, “typically when the user is asleep,” says Peterson, who was among those conducting SetPoint clinical trials.

“Trials have shown no serious adverse effects in 248 patients with severe RA,” Tracey says.

Physicians can adjust settings via a tablet that controls the device through the skin. It needs recharging once weekly.

Post surgery, “some people report their joints normalizing as inflammation goes down,” Peterson says. “You not only treat the pain but may see anatomical changes.”

Who benefits

Tracey helped found SetPoint Medical in 2007. The FDA approved it July 2025 for RA patients who failed to benefit from one or more biologic medications. Clinical trials showed it aided 60-80% of users within a year, sometimes eliminating the need for painkillers.

Around 70% of those who suffer from RA are women, and it often strikes in middle age, reports the U.S. Centers for Disease Control and Prevention. About 1.5 million Americans suffer from RA.

SetPoint’s technology and its outcomes are profound for patients who have lived with chronic pain from rheumatoid arthritis, Peterson says.

“It won’t work for everyone,” says Chernoff, “but for some it works extremely well, with many no longer needing advanced RA medications.”

Where it’s headed

Chernoff says similar devices could help curb epilepsy, multiple sclerosis and deep depression.  

And to think: The idea started as a drawing on a napkin.

“That sketch was prophetic,” he says. “I wish I’d kept the napkin.” •