The Trump administration’s attacks on diversity, equity and inclusion programs threaten to derail efforts to fix racial ...
The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
A fingertip pulse oximeter distributed by Concord Health Supply, Inc., a family-owned business in Skokie, is earning praise as the best in class for home use by Wirecutter, The New York Times' popular ...
Image: Adobe Stock In this review, pulse oximeter inaccuracy due to darker skin tones was found in 30 out of 44 assessed studies. Prior to issuing this draft guidance, the FDA’s Medical Devices ...
Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means ...
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance summary documents discussing race and ethnicity/skin tone rose, according ...
At that time, the FDA cautioned that while pulse ox devices can be useful, the light-based, fingertip readers may be inaccurate among users with darker skin in addition to providing varying ...
The doctors and nurses didn’t believe Tomisa Starr was having trouble breathing. Two years ago, Starr, 61, of Sacramento, California, was in the hospital for a spike in her blood pressure.
Pulse oximeters were invented in 1974, and the evidence of flawed pulse oximeter readings in people with dark skin dates to the 1980s. One study, published in 2022, found that among more than ...
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients ...
The FDA's recommendations apply to pulse oximeters ... finger and then sending two wavelengths of light into the skin, the oximeter measures how much of the light is absorbed and estimates ...