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.

Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.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.

The Daytona Beach plant that makes nearly a quarter of the IV fluids used in the United States is intact in the wake of Hurricane Milton’s tear across Florida, according to a company spokeswoman.The site, operated by B Braun Medical, gained prominence this week as a backup source for IV solutions because Hurricane Helene had flooded a major producer of the fluids in North Carolina and left hospitals from California to Virginia with diminishing supplies.Company workers and officials from the federal Administration for Strategic Preparedness and Response took pre-emptive measures before Milton arrived, loading trucks full of finished IV medical products to ship them out of the storm’s reach through the night Tuesday. Allison Longenhagen, a company spokeswoman, said on Thursday that the manufacturing and distribution site at Daytona Beach was intact, and would reopen on Friday. She said a more complete update would be issued later Thursday.The threat to B Braun’s Florida plant worried officials, hospitals and people who rely on the fluids for nutrition, at-home dialysis and surgery because of the damage Hurricane Helene had done to a plant in Marion, N.C., run by Baxter, the nation’s leading maker of the products.Baxter ordinarily produces about 60 percent of the U.S. supply of IV products, or an estimated 1.5 million of the bags that are used each day, according to the American Hospital Association. Hospitals have begun canceling surgical procedures and rationing bags of the fluids while Baxter works to clean and restore its plant in Marion, which was extensively flooded.Early this week, Baxter provided hospital customers with just 40 percent of their usual deliveries of saline, dextrose and sterile water supplies. Baxter said Wednesday that it would increase deliveries to 60 percent.Other emergency measures were being taken to shore up gaps in the supply chain.On Wednesday, the Food and Drug Administration authorized temporary imports of Baxter fluids from Canada, Ireland, Britain and two plants in China. The company has not yet said when the imports would arrive, but said Thursday that trucks were shipping undamaged inventory from the North Carolina site.The patients most on edge about shortages are those who rely on a highly concentrated dextrose solution for nutrition. . Hospitals are conserving the fluids by giving some patients Pedialyte or Gatorade to drink, but those who rely on tube feeding for survival are less able to cut back.Beth Gore, chief executive of the Oley Foundation, which advocates for patients on long-term IV nutrition, said she had been hearing from dozens of families across the country who said they were told the supply for their children would be reduced or cut off.”We are all extremely concerned about the disproportionate harm that’s going to potentially happen to the home-care patients,” she said.

Officials are looking to foreign sources to ease shortages of IV bags caused by Hurricane Helene as hospitals begin rationing fluids to protect the sickest patients.U.S. officials are racing to approve airlifts of IV fluids from overseas manufacturing plants to ease shortages caused by Hurricane Helene that have forced hospitals to begin postponing surgeries as a way to ration supplies for the most fragile patients.The current shortage occurred when flooding coursed through western North Carolina and damaged a Baxter plant, which is now closed for cleaning. The plant makes about 60 percent of the United States’ supply of fluids used in IVs, for in-home dialysis and for people who rely on IV nutrition. They include premature babies in intensive care and patients who rely on tube feeding to survive.The situation could become even more dire now that Hurricane Milton is bearing down on Florida. On Tuesday, workers at B. Braun, makers of a fourth of the nation’s IV fluids, loaded trucks at the company’s plant in Daytona Beach with the medical bags and drove them north through the night to what they hoped would be a safer location.The Baxter plant, in Marion, N.C., and the B. Braun site in Daytona Beach manufacture about 85 percent of the nation’s supply of IV fluids. Experts on shortages have long pointed out the risk of such over-concentration of critical supplies, citing exposure to disasters like those now at hand. Even before the latest storm, supplies were tight and reflected a longstanding problem of how few companies are willing to produce crucial but low-cost and low-profit supplies.A spokeswoman for the B. Braun site in Florida said that the company was working with federal officials and that the plant’s staff would be off work Wednesday and planned to return on Friday once the hurricane had moved on.The supply crunch from flooding at the Baxter plant has led the company to limit hospital customers to 40 to 60 percent of their typical supplies this week. The American Hospital Association wrote to President Biden on Monday, seeking assistance to alleviate concerns about “substantial shortages of these lifesaving and life-supporting products.”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.

A top medical device regulator’s work overlapped at times with his wife’s legal representation of clients with business before the agency.Two members of Congress have asked an inspector general to investigate whether the top federal regulator for medical devices like pacemakers and artificial hips acted ethically in work that overlapped with that of his wife, a leading lawyer for device companies.The lawmakers cited an investigation by The New York Times that examined the intersection of the work of the regulator, Dr. Jeffrey Shuren of the Food and Drug Administration, and his wife, Allison Shuren, a co-chair of the drug and medical device practice at the prominent Washington office of Arnold & Porter.The two House Democrats who wrote a letter seeking an inquiry are Representatives Anna Eshoo, of California and ranking member of the health subcommittee, and Rosa DeLauro, of Connecticut and ranking member of the appropriations committee.The Times found several instances in which the couple’s work overlapped and could have posed conflicts of interest requiring Mr. Shuren’s recusal. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have stepped aside or sought approval to be involved in two matters to “avoid any potential appearance of bias.”“In circumstances such as these,” the congresswomen’s letter to the inspector general, Christi Grimm, said, “the only way to get to the truth and be fair both to the public and Dr. Shuren is through an independent review of the matter to determine whether this is simply an appearance of impropriety or actual inappropriate and unethical conduct.”A spokeswoman for the inspector general’s office of the Health and Human Services Department said that the letter was received Tuesday and that “we are reviewing it for appropriate action.”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.

The F.D.A. authorized AstraZeneca to prescribe the treatment online for at-home use after a study showed it was feasible.The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.The approval will allow, for the first time, an alternative to the annual flu shot that parents and caregivers can give to children and that adults can use on their own outside of a health-care setting. It would still require a prescription and is expected to be available from an online pharmacy next fall.AstraZeneca, which makes the treatment, said it would start a FluMist Home website, where people can fill out a questionnaire that will be reviewed by a pharmacist before the treatment is shipped to a person’s home. The mist will remain available from prescribers as an in-office treatment. The current out-of-pocket cost for a dose is about $35 to $45, but may be less depending on insurance coverage.“Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” said Dr. Peter Marks, director of the F.D.A.’s vaccine center, which authorized the at-home option.The agency required the company to study whether its instructions were clear and whether at-home administration was feasible. The agency concluded that it was, but advised caregivers to give the spray to those who are 2 to 17 years old.The flu takes a steep toll that varies greatly from year to year, according to an F.D.A. summary of data from the Centers for Disease Control and Prevention. From 2010 through 2023, hospitalizations have ranged from 100,000 to 700,000 each year, and from about 4,900 to 51,000 people have died.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.

Consumer Reports found lead in a variety of products, at a time when federal regulators are seeking authority from Congress to combat the problem of heavy metals in foods.One dozen of 36 cinnamon products tested by a consumer group contained elevated levels of lead, according to a study released on Thursday that reinforced concerns about metals in foods after tainted cinnamon applesauce poisoned dozens of children last year.The study, by Consumer Reports, documented levels that were far lower than the amounts discovered last year.The Consumer Reports team tested the spice and found high levels in lead in 12 items sold at discount stores and ethnic markets, with lead levels reaching 3.5 parts per million. New York, the only state with tough lead standards in spices, recalls spices — among them curry powder, chili powder, cumin and five-spice powder — with more than one part per million of lead. Consumer Reports advised that people throw out items with that amount.Badia, one common brand, sold cinnamon with one part per million of lead, according to the report. The company did not respond to a request for comment.While the levels in the cinnamon applesauce recalled last year were “astronomical,” those in the new report were still 1,000 times as high as the levels that concern lead-exposure experts who focus on children’s health, said Tomás R. Guilarte, a neuroscience and environmental health professor at Florida International University.“These are extremely high levels of lead,” he said. “Clearly they shouldn’t be used.”Earlier this year, the Food and Drug Administration urged a series of recalls of cinnamon products. The discoveries provided the impetus for consumer advocacy groups to generate greater public awareness of the dangers of lead and other metals, and for the agency to push Congress for tough limits on those heavy metals in food.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 than 150 people were sickened from products sold at smoke and vape shops, providing evidence of the lax regulation of new food items.Nearly 160 people have reportedly been sickened this summer by eating mushroom-laced candy and chocolate bars that are widely available at vape and smoke shops, underscoring the dangers of a sprawling market of psychoactive products that pop up on store shelves with no review or regulation across the United States.Two deaths now under investigation may be related to the candy, samples of which were found to contain an illegal form of psilocin, an ingredient in so-called magic mushrooms, according to federal health officials.More than a third of those who became ill required hospitalization, suffering symptoms ranging from vomiting to loss of consciousness, seizures and hallucinations.The illnesses were traced to Diamond Shruumz chocolates and gummies, which the company recalled on June 28, officials said. Since then, the Food and Drug Administration has said that it was aware that the candy continued to be sold, and the agency released a list of about 2,300 shops that it said carried the products.Those items and other snacks, supplements and teas promising a mind-altering experience often contain ingredients like synthetic Delta-8-THC, or kratom, a botanical, that the F.D.A. considers hazardous.They are commonly sold in stores and do not have to meet quality standards, nor do they carry restrictions on sales to minors.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.

The percentage of middle and high school students reporting that they vaped tobacco products dropped to about a third of those students reporting use of e-cigarettes at a vaping peak in 2019, a new survey shows.The number of teenagers who reported using e-cigarettes in 2024 has tumbled from a worrisome peak reached five years ago, raising hopes among public health officials for a sustained reversal in vaping trends among teens.In an annual survey conducted from January through May in schools across the nation, fewer than 8 percent of high school students reported using e-cigarettes in the past month.That’s far lower than the apex, in 2019, when more than 27 percent of high school students who took the same survey reported that they vaped — and an estimated 500,000 fewer adolescents than last year.The data is from the National Youth Tobacco Survey, a questionnaire filled out by thousands of middle and high school students that is administered each year by the Food and Drug Administration and the Centers for Disease Control and Prevention. Overall, it found that just under 6 percent of middle and high school students reported vaping in the last month, down from nearly 8 percent among those surveyed last year. Use among high school students largely accounted for this year’s decline; middle school use stayed fairly steady.“I want to be unequivocally clear that this continued decline in e-cigarette use among our nation’s youth is a monumental public health win,” Brian King, the director of the F.D.A.’s tobacco division, said during a news briefing.Public health experts said the decline in teenage vaping may be due to several factors, including city and state flavored tobacco bans, a blitz of enforcement against sellers of flavored vapes and three public messaging campaigns aimed at young people about the dangers of vaping.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.

For 15 years, Dr. Jeffrey E. Shuren was the federal official charged with ensuring the safety of a vast array of medical devices including artificial knees, breast implants and Covid tests.When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.In a review of thousands of pages of court documents and F.D.A. records and dozens of interviews with current and former agency staff members and advocates, The Times identified some clients and several instances in which the Shurens’ roles intersected.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.