The young neurosurgeon in training couldn’t shake the sense of devastation. A baby died in his arms as he tried to resuscitate her. Her grandmother had tripped in the kitchen with a pot of boiling water, causing severe burns as the 11-month-old baby crawled across the floor. Dr. Kevin J. Tracey was the surgical resident on duty when she was brought to the hospital. He tended to baby Janice for a month, believing her treatment had put her on a path to recovery. Then, without warning, her health deteriorated. Nothing in medical school prepared Tracey for that moment: holding a fragile, beautiful baby as she took her last breath. “The fact she died was tragic and haunting and the source of many nightmares,” said Tracey, now the president and CEO of the Feinstein Institutes for Medical Research at Northwell Health, one of the largest hospital systems in the United States. “It was also the source of extraordinary frustration because there was no way then for us to understand or explain to her mother and her grandmother why she died.” The trajectory of Tracey’s career changed with that death in 1985. He emerged more motivated than ever to help those like Janice. Tracey dedicated his life to studying the role of inflammation in the body — and how best to treat it. He has since become one of the world’s preeminent neurosurgeons pioneering an entirely new category of care: bioelectronic medicine, revolutionizing care for patients around the world. “My personal philosophy is to ask questions that can be studied scientifically in order to forge a path to inventing new therapies,” he said. “That’s what I’ve focused on doing for 40 years.” 40 years on — and just getting started Tracey’s enthusiasm is infectious. When he speaks about how patients benefit from scientific breakthroughs, he lights up. His voice picks up a notch or two. Other times, he becomes emotional, the rare doctor willing to share his vulnerabilities. “Some people think science is about honor societies and prizes; some people think it’s about money,” he said. “I think it’s about patients. When you meet people who are benefitting from the work that your lab does, there is no better feeling in the world.” Tracey reached the pinnacle of his career last year when he and his team turned decades of laboratory science into a device approved by the US Food and Drug Administration that uses electrical signals to shut down harmful inflammation in patients with rheumatoid arthritis. Earlier this year, TIME named him to its list of top 100 innovators in health. In Tracey’s view, he’s just getting started. If the device works to tame inflammation in rheumatoid patients, he ponders, why won’t it work for patients suffering from other inflammatory diseases? “Imagine if we can stop inflammation in its tracks or stop inflammation from ever contributing to the onset of cancer or heart disease,” he said. “What would that do to the health span of (people on) the planet Earth?” The device shares a story unto itself — born out of an accidental discovery in his lab and a hand-drawn sketch on a napkin. It would take relentless dedication, rigorous research, and decades of patience to see it through. “I never imagined in 1998 that it would take until 2025 for it to be FDA-approved,” Tracey told CNN. FDA approves the SetPoint System About 1.5 million adult Americans live with rheumatoid arthritis (RA), a chronic disease that causes the immune system to mistakenly attack the lining of joints, leading to painful swelling, stiffness and chronic fatigue. Another 18 million are estimated to live with the condition worldwide, according to a 2019 report by the World Health Organization. It can affect people of any age, but typically it strikes those in their 50s. Women are about three times more likely to develop RA than men. RA can spread inflammation beyond joints to the heart, lungs, skin, eyes and blood vessels. There is no cure. It can be difficult to get a proper diagnosis. Symptoms come and go, flaring
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up, causing extreme pain. Anti-inflammatory medications like ibuprofen can provide relief, but over time the inflammation can become overwhelming. Patients taking corticosteroids or more advanced biologics complain of brain fog and dizziness. Those meds also can weaken the immune system, making patients vulnerable to infection, too. What Tracey and his team created is called the SetPoint System, a device about the size of a multivitamin that is implanted in the neck on the vagus nerve, the main conduit for the body’s inflammatory immune response to disease, bacteria and viruses. The device helps control the immune system in a more consistent way than medications. The FDA approved the device in July 2025 after a 242-patient randomized, double-blind trial demonstrated the SetPoint System was safe and effective — and provided relief to RA patients who were essentially out of traditional treatment options. It delivers a daily, one-minute stimulation to the vagus nerve with the aim of taming inflammation in patients. ‘A brand new person’ Jessica Hancock suffered from debilitating rheumatoid arthritis for more than a dozen years, beginning in her mid-30s. Pain shot through her body for simple tasks, like getting out of bed in the morning. “It’s frustrating when you’re so young and you’re like, ‘Why do I feel like I’m 90 years old?’” She’d tried an array of medications, including three biologics and chemotherapy. The relief was temporary. The pain always roared back. When a staffer at Northwell informed her about the FDA-approved device, Hancock cut her off: “Before she was even done, I was like: ‘Sign me up!’” She didn’t have any issues with insurance coverage, she said, because her husband works at Northwell. Her device was implanted in October. By January, she no longer needed any medications. Her pain was gone. “I was feeling fantastic with the stimulation. I had more energy. I didn’t hurt. I wasn’t cracking. I wasn’t swollen,” said Hancock, now 49. She added: “I feel like a brand-new person. I have not felt this good in 20 years.” Tracey’s message for health insurers About 30,000 patients tried to sign up for the device’s trial, Tracey said, showing how desperate patients are for relief when medications fail. But with FDA approval, Tracey said, an unexpected problem emerged. He said he’s hearing from doctors and hospitals across the country of persistent denials of coverage by health insurance companies. Tracey has a stern warning for them: Get on board. “You have 30,000 people who wanted this thing when there were 250 spots when it was still an experiment,” he said. “And you have the insurance company saying, ‘No, we’re not paying because it’s too new.’” He’s determined to make sure patients get covered by advocating for them and doing whatever he can to put pressure on insurers. The concept of the new FDA device, he said, first came about in the 1990s by “accident” in the lab. Researchers were studying the brains of mice with a stroke. When a lab tech injected an anti-inflammatory drug into the brain of a mouse, Tracey said, it “turned off the inflammation in the body of the mouse.” “This was a true WTF moment,” said Tracey. “I had no intention in that experiment of looking at inflammation of the body of the mouse.” It was his “aha” moment — when he realized the vagus nerve was a key to controlling inflammation. At a dinner, he drew a sketch on a napkin for his then-board chairman, explaining his belief. “That means that the nerve,” Tracey told him, “is acting like an anti-inflammatory signal.” He penned a book in 2025, “The Great Nerve,” further detailing why he believes the vagus nerve is key to health and vitality. For inventors, for scientists, for patients, Tracey’s message is one of optimism. “We’re on the cusp of launching an era where the science will become very, very useful,” he said. “And that means people are going to feel better — and that makes me very happy.”