Panel Backs FDA’s Proposed Approach On Pulse Ox Research
An FDA advisory panel supported an FDA proposal calling for larger clinical trials of pulse oximeters to improve their accuracy in people with darker skin tones.
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The first clearance from the US Food and Drug Administration for an over-the-counter fingertip pulse oximeter has gone to Masimo's MightySat Medical, which is now available at the company's website.
The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.
The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.