Forbes

What To Know About Skin Color Bias In Pulse Oximeters As FDA Discusses Potential Changes

A Food and Drug Administration advisory committee met Friday to figure out ways to make pulse oximeters more accurate when doing readings on darker skin both in hospitals and at home, after research ...
Business Wire

Masimo Announces the First FDA-cleared “Over-the-Counter” Fingertip Pulse Oximeter

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today FDA clearance of MightySat ® Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available ...
Monthly Prescribing Reference

FDA Clears MightySat Medical Fingertip Pulse Oximeter for OTC Use

Credit: Masimo. The pulse oximeter is intended for spot-checking of functional oxygen saturation of arterial hemoglobin and pulse rate. The Food and Drug Administration (FDA) has cleared Masimo ...
The Manila Times

Herz P1 Smart Oximeter Claims Evaluated: Best Pulse Oxygen Monitor Device on the Market with Clinical-Grade Accuracy

A 2026 informational report on the Herz P1 Smart Oximeter fingertip pulse oxygen monitor, covering the company's FDA 510(k) cleared positioning, ±2% SpO2 blood oxygen accuracy specifications, smart ...
TCTMD

FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters

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 In a draft guidance document issued on January 6, the agency outlined the steps it is taking to improve the ...
MM&M

FDA’s promised rules on pulse oximeters unlikely to end decades of racial bias

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 ...
Business Wire

Masimo Announces FDA Clearance of the Rad-G™ Pulse Oximeter

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today FDA clearance of the Rad-G™ Pulse Oximeter, a rugged handheld device that provides clinically proven SET ® pulse oximetry, ...
Healio

Pulse oximeters overestimate oxygen saturation in darker skin pigments

Please provide your email address to receive an email when new articles are posted on . Pulse oximeter inaccuracy due to darker skin tones was found in 30 out of 44 studies. Some studies showed a ...
Healio

FDA releases draft guidance on pulse oximeter study recommendations

Please provide your email address to receive an email when new articles are posted on . The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the ...
The Michigan Daily

UMich study finds inaccurate pulse oximeters may limit treatment options for Black patients with heart failure

Design by Matthew Prock. Buy this photo. “The pulse oximeter can overestimate the amount of oxygen that’s in the blood because of differences in skin pigment and skin tones,” Ketcham said. “That ...
FierceBiotech

FDA’s promised guidance on pulse oximeters unlikely to end decades of racial bias

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 ...