The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can be ...

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, PhD, of ...

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 ...

OAKLAND, Calif. -- The patient was in his 60s, an African American man with emphysema. The oximeter placed on his fingertip registered well above the 88% blood oxygen saturation level that signals an ...

The patient was in his 60s, an African American man with emphysema. The oximeter placed on his fingertip registered well above the 88% blood oxygen saturation level that signals an urgent risk of ...

Usha Lee McFarling is a former STAT reporter. Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at ...

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. She has ...

Dr. Takuo Aoyagi, a Japanese bioengineer, was the first to invent pulse oximetry in 1974. 2 The pulse oximeter is based on the light absorption characteristics of hemoglobin at different wavelengths.

The patient was in his 60s, an African American man with emphysema. The oximeter placed on his fingertip registered well above the 88% blood oxygen saturation level that signals an urgent risk of ...

OAKLAND, Calif. — The patient was in his 60s, an African American man with emphysema. The oximeter placed on his fingertip registered well above the 88% blood oxygen saturation level that signals an ...