The Priority Review

Tag

Masimo Corporation

1 story

  1. Regulation

    FDA finalizes class II status for hyperoxia monitoring device adjunct to pulse oximetry

    The FDA issued a final order on October 6, 2026, classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II with special controls. The order, effective October 6, 2026, codifies the classification that was first applied on October 12, 2023.