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“HoW” the FDA is Looking at Women and Medical Devices

  
  
  
“HoW” the FDA is Looking at Women and Medical Devices

Cardiovascular disease is the number one killer of women over 25 in the United States. Females account for 50.9% of the total US population and 63.1% of participants in National Institute of Health funded clinical research trials. However, female representation is lowest in studies for heart failure (29%), coronary artery disease (25%) and hyperlipidemia (28%) while females account for 51% of all individuals with heart failure, 46% for coronary heart disease, and 49% of those diagnosed with hyperlipidemia. Enrollment of woman in cardiovascular trials has increased over time, but remains low relative to their overall representation of the disease population as noted in a 2010 study titled “Representation of women in randomized clinical trials of cardiovascular disease prevention.” 

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