Medtronic has secured 510(k) clearance from the US Food and Drug Administration (FDA) for paediatric indications of the Invos 7100 cerebral/somatic oximetry system.
The clearance enables clinicians to use the Invos system to better monitor organ-specific oxygen levels and identify warnings signs for neonates and children through age 18.
By picking signals, the Invos system allows paediatric clinicians to take time-critical decisions related to haemodynamic management, ventilation, and resuscitation for premature infants, neonates, children, and other patients.
Earlier, the company secured approval for the Invos near-infrared spectroscopy monitoring system for adult patients.
To provide early alerts on changes in perfusion before other vital sign measurements, the Invos system delivers real-time measures of tissue perfusion and oxygenation.
Medtronic patient monitoring business chief medical officer Dr Sam Ajizian said: “There are so many time-critical conditions clinicians face when treating some of our youngest patients in intensive care units, from RSV to complex heart conditions and beyond.
“We see this as an opportunity to equip providers with technology that can help improve outcomes among the most vulnerable populations.”
The system’s advanced algorithms enables to measure acute alterations in hemodynamics, regional oxygen saturation, and oxygen metabolism.
To evaluate organs individually or in combination to track brain/body perfusion shifts, the system also offers continuous, noninvasive readings of organ-specific regional blood oxygen levels in up to four site specific areas selected by the care team and oxygen saturation from vascular beds.
From spring next year, Medtronic will commercialise the Invos 7100 system with paediatric indications across the globe.
In November this year, the company has secured the 510(k) clearance from the FDA for its PillCam Small Bowel 3 system for remote endoscopy procedures.
