A plan put forward by the US Food and Drug Administration and supported by most participants in a 2 February meeting of the agency’s anesthesiology and respiratory therapy devices advisory panel would more than double the minimum sample size needed in pulse oximeter clinical trials, as well as increasing the need for representation of people with darker skin tones. The move could be an important step for health equity, but what will it mean for device manufacturers?
Sam Ajizian, chief medical officer of Medtronic’s patient monitoring operating unit, spoke to Medtech Insight about his reaction to the...
