Please provide your email address to receive an email when new articles are posted on . The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the ...

Imagine having a heart or lung condition and you reach for a pulse oximeter, and because your skin happens to be darker, it misreads your oxygen saturation, and now, you need serious medical ...

The Food and Drug Administration's recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen. The FDA said ...

Manufacturers increasingly but still infrequently follow Food and Drug Administration (FDA) guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, ...