Disparities
FDA: Enroll More Women In Medical Device Trials
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Hundreds of thousands of women at risk for irregular heart rhythms have a battery-powered, iPod-sized gadget embedded in their chests. The implantable cardioverter defibrillator (ICD) can be a lifesaver, shocking a dangerously fast heartbeat back to normal. Yet the actual benefit to women is uncertain, because ICDs were approved by the Food and Drug Administration (FDA) based on clinical trials made up mostly of men.