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, ...

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 The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the ...

The FDA ‘clears’ medical devices that are sufficiently similar to devices that have already been approved by the FDA. Pulse oximeters intended for use in medical decision making or monitoring ...

The Food and Drug Administration’s recommendations apply to pulse ... approval for changes or updates to older oximeters. Monday’s announcement is only a draft. The FDA said it will take ...

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 ...