"Clinicians recommending the use of pulse oximeters to patients to monitor health conditions at home, and consumers using OTC [over-the-counter] pulse oximeters for medical purposes, should be ...

Masimo MightySat® Medical has received FDA clearance, making it the first and only FDA-cleared medical fingertip pulse oximeter available OTC.

Fingertip pulse oximeters are getting a rethink from the US Food and Drug Administration. In a draft guidance document issued on January 6, the agency outlined the steps it is taking to improve the ...

The pulse oximeter is intended for spot-checking of functional oxygen saturation of arterial hemoglobin and pulse rate.

FDA issues much-anticipated guidance on pulse oximeters The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin pigmentation.

Aboelata’s clinic has sued producers and stores that sell oximeters, demanding they pull the devices or add safety warnings to the labels. Many of her patients rely on home oxygen, which ...

For decades, widely used pulse oximeters have underestimated the oxygen needs of darker-skinned patients. Will the FDA's new guidelines fix that?

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.

On Friday, a U.S. Food and Drug Administration advisory panel addressed the ongoing issue of less accurate readings from pulse oximeters when used by individuals with darker skin.

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.

News FDA’s promised rules on pulse oximeters unlikely to end decades of racial bias State attorneys general and U.S. senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial ...