December 14, 2021 – Medtronic plc (Dublin, Ireland) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its INVOS 7100 cerebral/somatic oximetry system for children from birth through age 18.
The INVOS system picks up key signals to inform time-critical decisions by pediatric clinicians related to hemodynamic management, ventilation, and resuscitation for premature infants, neonates, children, and other patients treated by pediatric clinicians.
The INVOS near-infrared spectroscopy monitoring system has been previously cleared for use in adult patients and is the clinical reference standard for regional oximetry. The real-time measures of tissue perfusion and oxygenation provided by the INVOS 7100 system provide early alerts to changes in perfusion before other vital sign measurements. This data may indicate to clinicians that a patient is becoming critical — providing them the crucial time needed to treat newborns and young patients.
The technology inside the INVOS 7100 system delivers first-alert performance with its unique algorithms that measure acute alterations in hemodynamics, regional oxygen saturation, and oxygen metabolism. The system provides continuous, noninvasive readings of organ-specific regional blood oxygen levels in up to four site specific areas chosen by the care team and oxygen saturation from vascular beds to assess organs individually, or in combination to track brain/body perfusion shifts.
The INVOS 7100 system with the pediatric indications will be available worldwide for commercial use in spring 2022.