Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants ...
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
San Francisco-based Spry Health has raised $5.5 million to progress its clinical-grade wristband ... of ‘noise’ from other light sources. Pulse oximeters – which beam infrared light onto ...
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...
These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states ...
On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an ...