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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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      Trump Lays Out Vision for Bending the Federal Government to His Will

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      Former President Donald J. Trump vowed to vastly reshape the federal bureaucracy on Saturday in a wide-ranging, often unfocused speech at a rally in Wisconsin.He pledged to ultimately eliminate the Department of Education, redirect the efforts of the Justice Department and fire civil servants charged with carrying out Biden administration policies that he disagreed with.And he told his supporters that Robert F. Kennedy Jr., a leading vaccine skeptic who recently endorsed him, would be “very much involved” in a panel on “chronic health problems and childhood diseases.” Mr. Kennedy rose to prominence as a vaccine skeptic who promoted a disproved link between vaccines and autism.At one point Mr. Trump got in a dig at Vice President Kamala Harris, whom he has frequently accused without evidence of covering up signs that Mr. Biden was not fit to be president, by saying that he would support modifying the 25th Amendment to the Constitution to make it an impeachable offense for a vice president to cover up the incapacity of the president. It was a long-shot proposal at best, which would entail a difficult process that he does not control.Mr. Trump — who spent four years overseeing the federal bureaucracy — stood at an airport in front of hundreds of people holding “Drain the Swamp” signs distributed by his campaign and promised to “cut the fat out of our government for the first time meaningfully in 60 years,” a period that includes his presidency.Many of the proposals in Mr. Trump’s speech align with plans reported by The New York Times to conduct a broad expansion of presidential power over government, and to effectively concentrate more authority within the White House, if he wins in November.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 Big Border Change Harris Isn’t Talking About

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      A Biden administration border policy that has had a dramatic impact isn’t getting campaign play.Good evening. Tonight, my colleague Hamed Aleaziz, who covers immigration, looks at why the sharp drop in border crossings isn’t playing a bigger role in the presidential campaign. Plus, I want to hear about your favorite books about politics. — Jess BidgoodThe situation at the southern border looks very different these days.Gone are the headlines about surging border crossings crushing border communities and cities like New York struggling to fund housing for migrants who recently came to the country.The reality is that the numbers at the southern border have dropped to levels not seen before in the Biden administration — and lower than they were during parts of the Trump administration.The dramatic drop in border crossings came after a Biden administration policy seen by White House officials as a major success for an administration that has spent three years fighting Republican attacks over its handling of surging border crossings.Vice President Kamala Harris, however, has not focused on the dramatic change at the southern border in her presidential campaign. Tonight, I’ll explain what’s happening at the border, and offer some theories about why Harris isn’t talking it up.A border shutdown that workedThe border had seen a steady drop in crossings all year, but things took a dramatic turn in June. That’s when the Biden administration took a hallmark of the failed immigration bill from February — a measure allowing border officials to turn back migrants quickly when crossings exceed a certain level — and put a version of it into place via presidential proclamation.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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      Tras una gran semana para los demócratas, un buen día para Trump

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      El expresidente Donald Trump habló de políticas en Las Vegas y lució casi animado. En Arizona, se deleitó con el apoyo de un antiguo rival de campaña, Robert F. Kennedy Jr.[Estamos en WhatsApp. Empieza a seguirnos ahora]Fue un momento que el mundo político se había estado preguntando durante semanas.Si la vicepresidenta Kamala Harris tenía una buena convención, ¿podría descolocar aún más al expresidente Donald Trump?¿Toda esa prensa positiva para Harris —los grandes índices de audiencia, el apoyo de las celebridades y las bromas de Obama— podría llevar a Trump a lo profundo de sus patrones más autodestructivos?El viernes por la tarde, en un restaurante ítalo-mexicano de Las Vegas, parecía que teníamos la respuesta: no, al menos por ahora.Trump se presentó en el restaurante para promocionar su propuesta de “no gravar las propinas” entre los trabajadores del sector de servicios. En general se mantuvo centrado, no habló de sí mismo, sino de la difícil situación de los camareros y barmans. Les dijo que había sido Harris quien había roto un empate votando a favor de que el Servicio de Impuestos Internos contratara a 87.000 personas, las mismas que les arrebatarían las propinas que tanto les había costado ganar. (La verdad es un poco más matizada).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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      After a Big Week for Democrats, One Good Day for Trump

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      Former President Donald J. Trump talked policy in Las Vegas and seemed almost chipper. In Arizona, he reveled in the endorsement of a former campaign rival, Robert F. Kennedy Jr.It was a moment the political world had been wondering about for weeks.If Vice President Kamala Harris had a good convention, would it knock former President Donald J. Trump further off his game?Would all that positive press for Ms. Harris — the big ratings, celebrity froth and the double-barreled Obama zingers — drive Mr. Trump deeper into his most self-destructive patterns?At a Mexitalian restaurant in Las Vegas on Friday afternoon, we seemed to have our answer: It would not — at least for now.Mr. Trump had turned up at the restaurant to stand among service industry workers and promote his “no tax on tips” policy proposal. He stayed mostly focused — he did not talk all about himself but rather about the plight of waiters and bartenders. He told them it was Ms. Harris who cast a tiebreaking vote to provide the Internal Revenue Service with funds to hire 87,000 people — the very people who would be snatching their hard-earned tips. (The truth is a bit more nuanced than all that.)He did not devolve into any racist tangents about Ms. Harris, or call anyone a fat pig, or pick a fight with a popular governor from his own party, or tell dark tales about young women being raped, strangled and murdered by immigrants.He seemed almost chipper (at least more chipper than the night before, when he called into Fox News with his initial meandering reviews of Ms. Harris’s big speech). He talked about how the restaurant’s owner had started as a dishwasher and worked his way up, and joked with him about how he must have lots of cash now. The owner compared Mr. Trump to Ronald Reagan. “Thank you, Javier,” said Mr. Trump, looking touched.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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      Onstage Together in Arizona, Trump and Kennedy Signal New Alliance

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      Fresh from ending his long-shot presidential bid, Robert F. Kennedy Jr. appeared alongside Donald J. Trump at a rally for the former president in Arizona on Friday, a potential headline-grabber that the Trump campaign hopes will help its efforts in battleground states.Mr. Kennedy received almost a rock-star-style reception, walking onstage to fireworks, raucous cheering and the Foo Fighters song “My Hero” at an arena in Glendale, Ariz. But the political impact of his endorsement of Mr. Trump remains uncertain.Still, Mr. Trump’s allies on Friday relished the fact that the former president had won the backing of a member of America’s most storied Democratic family, albeit one who has had many of his relatives denounce him and his endorsement of Mr. Trump. Of all the outlandish political news stories of the summer, mused Charlie Kirk, the founder of Turning Point USA, which helped organize the rally, “maybe most remarkable of all: A Kennedy has endorsed a Republican.”Hours after Mr. Kennedy announced in nearby Phoenix that he was suspending his campaign and throwing his support behind Mr. Trump, he said at the rally — with Mr. Trump standing next to him — that he and the former president had found common ground.“We talked not about the things that separated us — because we don’t agree on everything — but on the values and the issues that bind us together,” Mr. Kennedy told the crowd, recalling a conversation he had with Mr. Trump. “Don’t you want a president that’s going to make America healthy again?”Despite their past conflicts, Mr. Kennedy and Mr. Trump have similar grievances that they could easily weave together on the campaign trail. They both blame a shadowy, bureaucratic deep state for many of the nation’s ills, and they argue that technology companies and Democrats want to suppress free speech.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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      In Las Vegas, Trump Calls Harris a ‘Copycat’ Over ‘No Tax on Tips’ Plan

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      Former President Donald J. Trump on Friday fumed over the fact that when it comes to exempting tips from being taxed, he and his rival, Vice President Kamala Harris, are on the same page.Mr. Trump, before a gathering of supporters at a Las Vegas restaurant, complained that Ms. Harris had stolen his idea and sought to cast her as an opportunist who was pandering to service industry workers by cribbing from one of his signature proposals.“She’s a copycat,” Mr. Trump said. “She’s a flip-flopper, you know. She’s the greatest flip-flopper in history. She went from communism to capitalism in about two weeks.”A Harris campaign spokesman declined to comment. This month, while in Las Vegas herself, Ms. Harris said she would seek to end federal income taxes on tips if she were elected. Mr. Trump first floated the idea in June, and it quickly garnered bipartisan support.He has publicly stewed over her embrace of the plan, especially in Nevada, a battleground state that Mr. Trump lost in 2016 and 2020.Before President Biden withdrew from the race in late July, Mr. Trump had appeared to be on a trajectory to end his electoral drought in the desert — where one of his hotels towers over the Strip. Mr. Biden, whose campaign called the “no tax on tips” overture a “wild campaign promise,” had been trailing Mr. Trump by an average of seven percentage points in Nevada.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 Campaign That Just Started Is Almost Over

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      Here’s my road map to the campaign’s remaining 74 days. If you blink, you might miss it.When Vice President Kamala Harris took the stage at the Democratic National Convention last night, she did not linger on her party’s bliss over the events of the past month. She used the opening words of the biggest speech of her life to change the subject.“OK,” Harris said. “Let’s get to business.”Harris’s crisp opening reflected the urgency of the clock, but also the hard reality of a hyper-compressed political calendar: Her presidential campaign is almost over, even though it has just begun, and both she and former President Donald Trump have hardly a second to waste in a close race.Because Harris has been atop her party’s ticket for only about a month, she and Trump have sprinted in a matter of days through campaign elements that normally take months. Harris has raced to define herself and her candidacy, running a campaign heavy on rallies and light on policy and taking questions from the press. Trump, who built a campaign premised on defeating President Biden, has struggled to change up his attacks. And now, with both conventions done and dusted, comes everything else.Much will be packed into the next 74 days, and much can change in that time. If your head is spinning, dear reader, I get it. Mine too! Here’s my road map to the rest of the campaign. If you blink, you might miss it.Coming up next: the summer doldrums.Ah, finally. The presidential race is set. It’s summertime. Candidates and voters can take a minute to breathe before the fall campaign ramps up.For like, two days.Harris is heading home to Washington this weekend, my colleagues Reid Epstein and Katie Rogers report. Trump, who is campaigning today in Las Vegas and Glendale, Ariz., also has no campaign rallies planned for Saturday and Sunday. That might be all the peace and quiet we get before …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