STAT28d
Fixing pulse oximeters requires federal might and possible legal action, researchers say
The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been ... documents submitted before the FDA made its suggestion to diversify skin ...
Healio13d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Pharmabiz18d
US FDA issues new draft guidance aimed to help improve performance of pulse oximeters across skin tones
The US Food and Drug Administration (FDA) published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care that are used to ...
technologynetworks14d
Pulse Oximeters Rarely Tested On Diverse Subjects
The FDA made the recommendation in 2013 ... medical devices that are sufficiently similar to devices that have already been approved by the FDA. Pulse oximeters intended for use in medical ...
CNN20d
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug ... with dark skin. The FDA announced Monday that ...
The Washington Post21d
FDA recommends fixing racial disparities in pulse oximeter readings
Companies can submit data to the FDA showing that their devices are effective on all skin tones. If the agency agrees, then the pulse oximeters would receive a label saying the device has been ...