Page 4 - News

The FDA has looked into pulse oximeter inaccuracy over the past several years, posting a warning in 2021 and holding an advisory panel meeting earlier this month. The agency has discussed the potential for results to be affected by factors including skin pigmentation and perfusion.

Masimo, a manufacturer of pulse oximeters, has worked to show if its devices suffer from biases. In its announcement, Masimo cited a 2023 study showing its RD Set device performed similarly in people with dark