EurekAlert!17h
Pulse oximeters infrequently tested by manufacturers on diverse sets of subjects
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
HME News1d
FDA issues draft guidance on pulse oximeters
The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a r ...
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
News Medical4d
Onyx 9500 Pulse Oximeter from Nonin Medical
Hundreds of thousands of people trust Onyx, the first self-contained digital fingertip pulse oximeter. Incorporating the electronics and sensor into one unit – the easy-to-use Onyx provides a ...
WTKR2d
FDA calling on pulse oximeter makers to make life-saving changes to devices
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
FDA issues much-anticipated guidance on pulse oximeters
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...
Too Old to Operate2d
FDA Drafts New Recommendations for More Inclusive Pulse Oximeter Testing
The U.S. Food and Drug Administration released draft guidelines on Jan. 6 proposing that manufacturers conduct larger, more ...
STAT11d
Fixing pulse oximeters requires federal might and possible legal action, researchers say
Work by device manufacturers to improve the performance of pulse oximeters on people with darker skin has progressed little since the Food and Drug Administration asked manufacturers in 2013 to ...
devdiscourse3d
FDA Proposes Stricter Testing for Pulse Oximeters on Diverse Skin Tones
The FDA has proposed new guidelines requiring manufacturers of pulse oximeters to gather comprehensive data on device performance across various racial groups. This move aims to improve accuracy for ...