FDA Plans Meeting On Pulse Oximeter Accuracy
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.
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Sajid Javid, the UK’s secretary of state for health and social care, wants to collaborate with the US Department of Health and Human Services to investigate biases in monitoring and diagnostic devices.
The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.
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.