Medtronic Gets 510(k) Clearance for its Invos 7100 Cerebral/Somatic Oximetry System

Medtronic has received the 510(k) clearance from the FDA for its Invos 7100 cerebral/somatic oximetry system for children up to age 18.

The near-infrared spectroscopy monitoring system is designed to provide pediatricians with information for time-critical decisions on hemodynamic management, ventilation and resuscitation for premature infants, neonates, children and other patients.

The system was previously cleared for use in adult patients. Medtronic said it will begin marketing the device for pediatric use in the spring.