FDA Clears Masimo 510(k) for O3 Regional Oximetry

FDA has cleared a Masimo 510(k) for its O3 regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure being performed, the company says. The device uses near-infrared spectroscopy to continuously monitor absolute and trended regional tissue oxygen saturation in the cerebral region.

Clearance was based on data from a study involving 27 subjects that compared cerebral oxygen saturation measurements obtained from O3 with saturations obtained from blood samples (SavO₂) through induced hypoxia. “Follow up studies with O3 extended the subject pool to 74 subjects and demonstrated that O3 maintained its absolute and relative accuracy,” the company says.