medtechdive2d
J&J coordinating with FDA on US pause of Varipulse due to safety risks
Johnson & Johnson executives, on a Wednesday earnings call, did not provide a timeline for when U.S. Varipulse cases will ...
CNN18d
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Pulse oximeters are small finger-clamp devices ... in patients with darker skin when it comes to both performance and safety. “The current document also proposes very general tolerances for ...
The Hill18d
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
Pulse oximeters clip on to a person’s finger ... FDA warned doctors and the public about the device’s limitations in a 2021 safety communication. Melanin absorbs light, so the darker a person ...
Star Tribune18d
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
One year into the pandemic, the FDA issued a safety communication to note pulse oximeters can return inaccurate results because of elements including skin pigmentation. A 2023 study in the ...