BRIEF-FDA Proposes Updated Recommendations To Help Improve Performance Of Pulse Oximeters Across Skin Tones

Jan 6 (Reuters) -

• FDA PROPOSES UPDATED RECOMMENDATIONS TO HELP IMPROVE PERFORMANCE OF PULSE OXIMETERS ACROSS SKIN TONES

• FDA: UPDATED DRAFT RECOMMENDATIONS AIMED AT HELPING GENERATE A MORE REPRESENTATIVE STUDY OF INTENDED POPULATION FOR PULSE OXIMETERS

• FDA: CURRENT SCIENTIFIC EVIDENCE SUGGESTS THERE ARE SOME ACCURACY DIFFERENCES IN PULSE OXIMETER PERFORMANCE BETWEEN DIFFERENT SKIN PIGMENTATION

• FDA: PROPOSED NEW DRAFT RECOMMENDATIONS ON HOW TO GATHER CLINICAL DATA TO IMPROVE STUDY DESIGN FOR PULSE OXIMETERS, ACROSS RANGE OF SKIN PIGMENTATION

• FDA-EXPECTS SOME PULSE OXIMETERS CURRENTLY MARKETED MAY MEET UPDATED PERFORMANCE CRITERIA WITHOUT NEED FOR SIGNIFICANT HARDWARE/SOFTWARE MODIFICATIONS

((Reuters.Briefs@thomsonreuters.com;))