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 ...

The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people with darker skin — an effort that comes years after research showing that ...

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 The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

Holly has a degree in Medical Biochemistry from the University of Leicester. Her scientific interests include genomics, personalized medicine, and bioethics.View full profile Holly has a degree in ...

The Trump administration’s attacks on diversity, equity and inclusion programs threaten to derail efforts to fix racial disparities associated with pulse oximeters — just as the federal government was ...

The FDA has published a set of long-awaited recommendations to the industry to help ensure pulse oximeters work correctly across all skin tones. The agency’s new draft guidance document comes after ...

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. In 2022, Noha Aboelata noticed something troubling. The founding CEO ...

The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical ...

Research confirms that skin pigmentation can reduce the accuracy of pulse oximeters. Researchers found that red light, a key component in pulse oximetry, is more strongly attenuated in pigmented skin.