EMS19h
Study: Only 25% of pulse oximeters tested for skin-tone bias post-FDA guidance
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 ...
Healio13h
Diversity in pulse oximeter clearance summaries increases after 2013 FDA guidance
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...
Daily Herald19h
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...
EurekAlert!1d
Pulse oximeters infrequently tested by manufacturers on diverse sets of subjects
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 ...
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
HME News1d
FDA issues draft guidance on pulse oximeters
The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a r ...
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...
MassDevice29d
FDA clears Mindset Medical’s contactless pulse measurement app
Mindset Medical announced that it received FDA 510(k) clearance for its contactless pulse rate measurement device, the IVC app. This marks Mindset Medical’s first clearance and follows a Series ...
Yahoo Finance29d
Zynex UCSF Study Results Demonstrate Laser Technology Benefits in Resolving Racial Bias of Current LED Pulse Oximeters
ENGLEWOOD, Colo., Dec. 12, 2024 /PRNewswire/ -- Zynex, Inc. (NASDAQ: ZYXI) ("Zynex", "ZMS", "we" or the "Company"), an innovative medical technology company ...