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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The company ordered the recall after three stent fractures and a death occurred in an 89-participant clinical trial.
The program will be open to roughly a hundred device firms with traditional 510(k)s under review between March and May of this year.
Shifting trial design and missing data, plus little evidence of benefit, worked against the paclitaxel-coated balloon, panelists and US FDA speakers said.