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Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a time when tech in healthcare is blowing up. Her role involves regulating devices that now handle critical functions, like scanning for cancer, translating brain signals for those who’ve lost speech, and acting as hearing aids in the form of Apple AirPods. These devices have become essential to patient care, and the FDA’s oversight is under heavy scrutiny. With the budget at $790 million and a staff of 2,500, this division’s task list is stacked. And with Tarver stepping in to replace Dr. Jeffrey Shuren, who pushed for faster device approvals and grew close to industry insiders, there’s even more pressure to act quickly but carefully. In Shuren’s tenure, some of these close ties drew criticism, especially with his wife representing certain device makers, bringing ethical concerns. With Tarver now in charge, expectations are high. She’s got to handle the massive influence of big tech in the medical device space and maintain standards that protect public health. Critics are watching, and Congress is paying attention. High-profile tech developments, like brain-computer interfaces, add even more complexity. Brain-computer interfaces and Elon Musk’s influence Brain-computer interfaces (BCIs) are one of the hottest and most challenging areas Tarver’s team will oversee. These devices decode brain signals and help people with paralysis regain movement, like playing Mario Kart or controlling a computer. The FDA’s medical device division is responsible for approving trials and eventually deciding if these devices hit the market. Elon Musk’s company Neuralink, in particular, has been at the forefront of this field, developing implants that allow users to control digital devices with their thoughts. Musk’s ambitions extend to devices he claims could restore sight to the blind. He is also loud…

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Filed under: News - @ November 3, 2024 10:10 am