Getinge launches smaller Edi catheter in U.S. after FDA clearance
Getinge has received FDA clearance for a new Edi catheter designed for premature infants weighing between 500 and 1,000 grams. The device will now be available in the U.S. market.
Medical technology company Getinge has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new 6Fr/48 cm Edi catheter. This smaller device is specifically engineered for premature infants weighing between 500 and 1,000 grams.
The U.S. market introduction follows the product's availability in international markets since 2025. The launch is significant given that over 350,000 babies are born prematurely in the United States annually, with more than 22,000 classified as extremely low birth weight.
The Edi catheter is designed to work with Getinge's NAVA (Neurally Adjusted Ventilatory Assist) technology. This system aims to provide respiratory support that is synchronized with the patient's own breathing signals, potentially improving outcomes for neonates.
This clearance allows Getinge to extend its NAVA-supported care to the smallest and most vulnerable patient population in neonatal intensive care units. The company's existing NAVA technology is used to help patients achieve better synchronization between their own respiratory efforts and the ventilator's support.