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.

Manufacturers may need to study pulse oximeters across the full spectrum of human skin if the US Food and Drug Administration puts a proposed clinical trial approach into action.

The plan, discussed at an advisory committee meeting on 2 February, addresses persistent problems with the accuracy of pulse oximeters...