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    From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

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    The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology.There are now artificial intelligence programs that scan M.R.I.s for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it.Medical device technology is now deeply entrenched in many patients’ health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration.Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the F.D.A.’s device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Dr. Shuren’s wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny.Dr. Michelle Tarver, an ophthalmologist and a 15-year veteran of the F.D.A.’s medical device division.U.S. Food and Drug AdministrationMore broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry’s influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division’s mission in the coming years. Among the issues Dr. Tarver will encounter:Brains, computers and Elon MuskFew devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise — and return function to people who have lost it.Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Can Exercise Help With I.B.S.?

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      Working out is not a cure-all for your gut, but it can be an important part of managing your symptoms.Exercise is often heralded as a “wonder drug” for just about every part of the body, whether it’s the brain, the heart, the pelvic floor or the lungs. But what about the stomach?While going for a jog with a sensitive stomach is rarely appealing, regular activity is an important part of treating many gut maladies, particularly irritable bowel syndrome. In fact, a lack of movement, perhaps because of an injury, can even be the initial trigger for I.B.S.“Exercise is part of lifestyle management, which is the first-line treatment for any patient with I.B.S. or other bowel-related issues,” said Dr. Anthony Lembo, the research director of the Cleveland Clinic’s Digestive Disease Institute.What does exercise have to do with a healthy stomach?Studies have consistently shown that I.B.S. patients who exercise regularly have fewer symptoms than those who don’t. But, while experts agree that mild to moderate exercise is beneficial, the reasons are a bit of a mystery.I.B.S. is caused by miscommunication between the brain and the gut, which leads to pain and bloating during the normal digestion process. For some people it primarily causes constipation, while others experience mostly diarrhea or a combination of the two.The digestive system has a complex network of neurons — sometimes called the “second brain” — that controls blood flow, secretions and hundreds of gut functions through the vagus nerve, which connects the brain to organs in the body. As such, the brain has an outsize influence on the digestive tract, and vice versa.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      California Passes Law Protecting Consumer Brain Data

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      The state extended its current personal privacy law to include the neural data increasingly coveted by technology companies.On Saturday, Governor Gavin Newsom of California signed a new law that aims to protect people’s brain data from being potentially misused by neurotechnology companies.A growing number of consumer technology products promise to help address cognitive issues: apps to meditate, to improve focus and to treat mental health conditions like depression. These products monitor and record brain data, which encodes virtually everything that goes on in the mind, including thoughts, feelings and intentions.The new law, which passed both the California State Assembly and the Senate with no voter opposition, amends the state’s current personal privacy law — known as the California Consumer Privacy Act — by including “neural data” under “personal sensitive information.” This includes data generated by a user’s brain activity and the meshwork of nerves that extends to the rest of the body.“I’m very excited,” said Sen. Josh Becker, Democrat of California, who sponsored the bill. “It’s important that we be up front about protecting the privacy of neural data — a very important set of data that belongs to people.”With tens of thousands of tech startups, California is a hub for tech innovation. This includes smaller companies developing brain technologies, but Big Tech companies like Meta and Apple are also developing devices that will likely involve collecting vast troves of brain data.“The importance of protecting neural data in California cannot be understated,” Sen. Becker said.The bill extends the same level of protections to neural data that it does for other data already considered sensitive under the California Consumer Privacy Act, such as facial images, DNA and fingerprints, known as biometric information.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      How Does Pregnancy Change the Brain? Clues Are Emerging.

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      As hormones surge, some brain areas shrink in what scientists say may be a fine-tuning that helps mothers bond with and care for their babies.Research is revealing intriguing clues about how pregnancy changes the brain. Studies scanning women’s brains before and after pregnancy have found that certain brain networks, especially those involved in social and emotional processing, shrink during pregnancy, possibly undergoing a fine-tuning process in preparation for parenting. Such changes correspond with surges in pregnancy hormones, especially estrogen, and some last at least two years after childbirth, researchers have found.A new study, published Monday in the journal Nature Neuroscience, adds to the picture by documenting with M.R.I.s brain changes throughout one woman’s pregnancy. It confirms previous results and adds detail, including that white matter fibers showed greater ability to efficiently transmit signals between brain cells, a change that evaporated once the baby was born.“What’s very interesting about this current study is that it provides such a detailed mapping,” said Elseline Hoekzema, a neuroscientist who heads the Pregnancy and the Brain Lab at Amsterdam University Medical Center and has helped lead studies analyzing brain scans of more than 100 women before and after pregnancy.Dr. Hoekzema, who was not involved in the new study, said it showed that along with previously documented “longer-lasting changes in brain structure and function, more subtle, transient changes also occur.”Dr. Ronald Dahl, director of the Institute of Human Development at the University of California, Berkeley, who was not involved in the new study, said the emerging research reflected the key role of hormones in transitions like puberty and pregnancy, guiding neurological shifts in priorities and motivations.“There is that sense that it’s affecting so many of these systems,” he said. The study participant, Elizabeth Chrastil, is a neuroscientist at the University of California, Irvine. She became pregnant in 2019, at 38, after in vitro fertilization. That allowed precise tracking of her pregnancy from the start.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      The N.F.L. Now Allows Helmet Caps

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      Do they work?Now that the N.F.L. season has begun, you may have noticed football players wearing a strange sort of cover over their helmets. It’s called a Guardian Cap, and it adds a layer of foam to the outside of the helmet, with the aim of reducing brain injuries.N.F.L. players have worn the caps during summer practice for the past few years, but this is the first season the league is allowing them in games. A handful of players wore them during the opening weekend.The company behind the caps, Guardian Sports, says they reduce the force of the impact when a player’s head is hit. But what does that mean? And do they protect against concussions?Erin Hanson, Guardian’s founder and owner, said an N.F.L. study found that when players used Guardian helmet caps in practice, the number of concussions fell by more than 50 percent.Yet, Guardian also has a disclaimer on its website: “No helmet, practice apparatus or helmet pad can prevent or eliminate the risk of concussions or other serious head injuries while playing sports. Researchers have not reached an agreement on how the results of impact absorption tests relate to concussions.”In a telephone interview, Hanson emphasized that it was unrealistic to think that the cap would prevent all concussions.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Do You Have Healthy Brain Habits? Take This Quiz to Find Out.

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      What can I do to take good care of my brain and lower my risk for a neurological disease? That’s the No. 1 question neurologist Dr. Jonathan Rosand hears from his patients (and their family members) at the Massachusetts General Hospital McCance Center for Brain Health. To help answer it, he and his colleagues, with […] More

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      A Personalized Brain Pacemaker for Parkinson’s

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      When Shawn Connolly was diagnosed with Parkinson’s disease nine years ago, he was a 39-year-old daredevil on a skateboard, flipping and leaping from walls, benches and dumpsters through the streets of San Francisco. He appeared in videos and magazines, and had sponsorships from skateboard makers and shops.But gradually, he began to notice that “things weren’t really working right” with his body. He found that his right hand was cupping, and he began cradling his arm to hold it in place. His balance and alignment started to seem off.Over time, he developed a common Parkinson’s pattern, fluctuating between periods of rapid involuntary movements like “I’ve got ants in my pants” and periods of calcified slowness when, he said, “I could barely move.”A couple of years ago, Mr. Connolly volunteered for an experiment that summoned his daring and determination in a different way. He became a participant in a study exploring an innovative approach to deep brain stimulation.In the study, which was published Monday in the journal Nature Medicine, researchers transformed deep brain stimulation — an established treatment for Parkinson’s — into a personalized therapy that tailored the amount of electrical stimulation to each patient’s individual symptoms.The researchers found that for Mr. Connolly and the three other participants, the individualized approach, called adaptive deep brain stimulation, cut in half the time they experienced their most bothersome symptom.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      How to Exercise to Improve Your Mood

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      Physical activity can brighten your outlook and calm your nerves — if you do it strategically.We’ve all encountered that person who comes back from the gym or a run seemingly high on life. In fact, scientists say that even a single bout of exercise can alter your neurochemistry in ways that create feelings of hope, calm, connection and a generally better mood.But for others, a workout just leaves them feeling worn out.“It’s normal not to find exercise rewarding,” said Daniel Lieberman, an evolutionary biologist at Harvard University. “There’s nothing wrong with you.”While some people are simply more genetically or psychologically inclined to enjoy exercise, recent discoveries have helped experts understand why it can be such a high. And, they say, by making a few changes to your workout, you can train your body and mind to find exercise more pleasurable.It’s not just about endorphins.Scientists once thought the rush people felt from exercise came exclusively from endorphins, which act like natural opioids in the brain by relieving pain. But in recent decades, researchers have discovered a more complex cocktail of other key “feel-good” chemicals produced during movement.Each ingredient plays a distinct but complementary role, said Julia Basso, an assistant professor at Virginia Tech who runs a lab studying the effects of exercise on the brain. “These neurochemicals are really working in tandem,” she said.The most potent players appear to be endocannabinoids, which share similar molecular structure with THC, and bind to the same receptors in the brain — giving you that buzzy feeling that all is right in the world.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      A Blood Test Accurately Diagnosed Alzheimer’s 90% of the Time, Study Finds

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      It was much more accurate than primary care doctors using cognitive tests and CT scans. The findings could speed the quest for an affordable and accessible way to diagnose patients with memory problems.Scientists have made another major stride toward the long-sought goal of diagnosing Alzheimer’s disease with a simple blood test. On Sunday, a team of researchers reported that a blood test was significantly more accurate than doctors’ interpretation of cognitive tests and CT scans in signaling the condition.The study, published Sunday in the journal JAMA, found that about 90 percent of the time the blood test correctly identified whether patients with memory problems had Alzheimer’s. Dementia specialists using standard methods that did not include expensive PET scans or invasive spinal taps were accurate 73 percent of the time, while primary care doctors using those methods got it right only 61 percent of the time.“Not too long ago measuring pathology in the brain of a living human was considered just impossible,” said Dr. Jason Karlawish, a co-director of the Penn Memory Center at the University of Pennsylvania who was not involved in the research. “This study adds to the revolution that has occurred in our ability to measure what’s going on in the brain of living humans.”The results, presented Sunday at the Alzheimer’s Association International Conference in Philadelphia, are the latest milestone in the search for affordable and accessible ways to diagnose Alzheimer’s, a disease that afflicts nearly seven million Americans and over 32 million people worldwide. Medical experts say the findings bring the field closer to a day when people might receive routine blood tests for cognitive impairment as part of primary care checkups, similar to the way they receive cholesterol tests.“Now, we screen people with mammograms and PSA or prostate exams and other things to look for very early signs of cancer,” said Dr. Adam Boxer, a neurologist at the University of California, San Francisco, who was not involved in the study. “And I think we’re going to be doing the same thing for Alzheimer’s disease and hopefully other forms of neurodegeneration.”In recent years, several blood tests have been developed for Alzheimer’s. They are currently used mostly to screen participants in clinical trials and by some specialists like Dr. Boxer to help pinpoint if a patient’s dementia is caused by Alzheimer’s or another condition.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More