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FDA Expands Approval For Medtronic's INVOS 7100 Cerebral/somatic Oximetry System For Pediatric Use

Healthcare technology firm Medtronic plc (MDT) announced Tuesday 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.

The INVOS 7100 system with the pediatric indications will be available worldwide for commercial use in spring 2022.

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