Problems with pulse oximeters have been known for decades, but it wasn’t until the pandemic that the real dangers to Black patients became clear.

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make ...

The FDA made the recommendation in 2013, following reports that pulse oximeters—devices that measure blood-oxygen levels by shining light through the skin—can be less accurate when used on ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far ... s blood oxygen levels, are less accurate on people with darker skin.

Some have criticized the lack of regulation for accuracy surrounding these devices. CEO John Hastings of Plymouth’s Nonin Medical, which launched the fingertip pulse oximeter in 1995 ...

The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen.

This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. The Food and Drug Administration on Monday released ...

A home pulse oximeter is an easy and painless way to ... this one has undergone multiple independent clinical tests for accuracy—and it performed exceptionally well in each test," Wirecutter ...