The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
Another is for manufacturers to “prominently display appropriate warnings” in the devices’ instructions, such as informing patients that “differences in skin pigmentation may cause differences in ...
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 pulse tone can be switched off and has an adjustable volume. For documentation purposes, the stored SpO2 and pulse values can be transmitted to a printer or to a PC by using the integrated ...
In 1995 Nonin Medical revolutionized pulse oximetry with the Onyx. Hundreds of thousands of people trust Onyx, the first self-contained digital fingertip pulse oximeter. Incorporating the ...
Reports of race, ethnicity, or skin tone occurred 320 times in 12.5% of 767 FDA summary documents that discussed pulse oximeter performance testing from 1996 to 2024, reported Kadija Ferryman ...
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to a new study.
Szyman led Edwards Lifesciences’ critical care unit for more than a decade before BD acquired the group last year. Her ...
Pulse oximeter apple on sale watch series 5, U.S. judge rules Apple Watch infringed Masimo s pulse oximeter on sale ...
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 ...