RAPS

Guidance Explains 510(k) Pathway Requirements for Pulse Oximeters

The US Food and Drug Administration (FDA) has released a new guidance document on using the 510(k) pathway to clear two types of pulse oximeters, small non-invasive sensors that are used to measure a ...
RAPS

FDA advisors want standards, labeling to address racial disparities with pulse oximeters

A panel of external US Food and Drug Administration (FDA) experts are urging more research to improve the efficacy of pulse oximeters in people with darker skin, creating a standard skin pigmentation ...
Wareable

Best pulse oximeters in 2026: Tested and compared

That’s where pulse oximeters come in. These small devices measure your heart rate and SpO₂. They give you another way to understand how your body responds during exercise and recovery. Also, they may ...
wtvr

FDA warns pulse oximeters may not work as well on people of color

WASHINGTON, D.C. – The Food and Drug Administration (FDA) is warning that the pulse oximeters that have become essential tools in the fight against COVID-19 may not work as well on people of color. A ...
STAT

FDA-funded study of pulse oximeter accuracy yields surprising and confusing results

Anil Oza is a general assignment reporter at STAT focused on the NIH and health equity. You can reach him on Signal at aniloza.16. Rather than provide clarity on how to reduce racial bias in pulse ...