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The Boston Globe

Health & wellness

Heart device upgrades get speedy approval making safety risks more likely, study finds

In order to get a new implantable heart device on the market, manufacturers must undergo an extremely rigorous approval process conducted by the US Food and Drug Administration; this helps ensure that the pacemaker or defibrillator implanted in a person’s heart doesn’t misfire or stop working altogether.

But most devices now approved to be implanted in patients have gone through a much speedier “supplement” review because they’re considered to be upgraded versions of older devices with just minor modifications, according to a new study conducted by Brigham and Women’s Hospital researchers.

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