Pulse Oximeters May Be Less Accurate For Dark-Skinned People, FDA Warns
The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.
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US regulators plan to hold a public meeting later this year to address concerns the devices are less accurate for people with darker skin tones.
The company announced new research investments and partnerships with the American Diabetes Association and the T1D Exchange to address racial disparities in treatment of diabetes.
For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component
Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.