By Michael Dabaie
Medtronic PLC said the US Food and Drug Administration has approved 510(k) for its INVOS 7100 cerebral/somatic oximetry system for children from birth to 18 years of age.
The FDA approval expands use of the system, allowing clinicians to better monitor organ-specific oxygen levels and identify early warning signs for newborns and children, the company said.
The INVOS system picks up key cues to provide information about time-critical pediatric clinician decisions regarding hemodynamic management, ventilation, and resuscitation for premature infants, neonates, children, and other patients treated by pediatric clinicians.
The INVOS 7100 system with the pediatric indications will be available for commercial use worldwide in the spring of 2022, Medtronic said.
Write to Michael Dabaie at michael.dabaie@wsj.com
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