Medtronic cerebral/somatic oximetry system wins FDA clearance
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its INVOS 7100 cerebral/somatic oximetry […]
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its INVOS 7100 cerebral/somatic oximetry system.
INVOS 7100, which Medtronic designed to pick up key signals to inform time-critical decisions by pediatric clinicians, received clearance for children from birth through age 18. The signals it picks up are 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 previously garnered clearance for adult patients. The real-time measures of tissue perfusion and oxygenation provided by INVOS 7100 provide early alerts to changes in perfusion before other vital sign measurements, according to a news release.
Medtronic designed INVOS 7100 with unique algorithms for measuring acute alterations in hemodynamics, regional oxygen saturation and oxygen metabolism. The platform provides continuous, noninvasive readings of organ-specific regional blood oxygen levels in four site-specific areas chosen by the care team, as well as oxygen saturation from vascular beds to assess organs individually or in combination to track brain/body perfusion shifts, Medtronic said.
The company intends to make the INVOS 7100 system with pediatric indications available worldwide for commercial use in spring 2022.
“Timing is critical for vulnerable pediatric patients, and the INVOS 7100 system can alert clinicians to changes in patient condition before traditional monitored parameters even react,” President of Medtronic’s Patient Monitoring business Frank Chan said in the release. “The INVOS™ 7100 system can help clinicians decide if intervention is necessary — a core component in successful outcomes. And our technology consistently enables users to determine if they need to intervene sooner.”
Original Article: (https://www.massdevice.com/medtronic-cerebral-somatic-oximetry-system-wins-fda-clearance/)