The FDA granted 510(k) clearance to Getinge’s 6Fr/48 cm Edi catheter designed for premature infants weighing between 500 and 1,000 grams.


RT’s Three Key Takeaways:

  1. Regulatory Clearance: The FDA has granted 510(k) clearance to Getinge for its 6Fr/48 cm Edi catheter designed for premature infants weighing between 500 and 1,000 grams.
  2. Synchronized Ventilation Support: The device captures the electrical activity of the diaphragm, allowing ventilator support to match a patient’s natural breathing efforts through Neurally Adjusted Ventilatory Assist (NAVA) technology.
  3. Dual-Function Clinical Utility: Serving as both an enteral feeding tube and a diagnostic sensor, the catheter will be introduced to neonatal intensive care units across the US by the end of 2026.


Getinge has received 510(k) clearance from the FDA for its smallest Edi catheter, a 6Fr/48 cm device engineered for premature infants weighing between 500 and 1,000 grams, according to the company.

The catheter has been available in commercial markets outside the US since 2025 and is scheduled for US availability by the end of 2026, the company reported. According to data from the National Vital Statistics Reports cited by Getinge, more than 350,000 infants are born prematurely each year in the US, including over 22,000 infants categorized as extremely low birth weight.

Expanding Synchronized Ventilation in the NICU

The Edi catheter operates in conjunction with Getinge’s Neurally Adjusted Ventilatory Assist (NAVA) software on compatible Servo ventilators, according to the manufacturer. By continuously measuring the electrical activity of the diaphragm (Edi), the catheter enables mechanical ventilator breath delivery to coordinate in real time with the infant’s neural respiratory drive, effort, and cycle timing.

According to the company, the device serves a dual clinical function by operating simultaneously as a standard feeding tube and as a sensor to monitor diaphragmatic electrical signals in neonatal intensive care units.

“The smallest babies often have the most complex respiratory needs,” said Elin Frostehav, president acute care therapies at Getinge. “This clearance allows us to bring our latest Edi catheter to hospitals across the U.S. and support clinicians caring for extremely premature infants. By expanding the range of patients who can benefit from NAVA, we can help deliver more personalized respiratory support to some of the most vulnerable patients in healthcare.”

Targeting Extremely Low Birth Weight Care

Getinge stated that extending NAVA capabilities to patients weighing under 1,000 grams provides clinicians with additional options to optimize patient-ventilator synchrony during early developmental stages.

“Caring for extremely low birth weight infants requires therapies that can be adapted to each patient’s individual needs,” said Dr Miray Kärnekull, medical director, critical care at Getinge. “The addition of this smaller catheter gives clinicians the ability to use established NAVA technology with even smaller babies than before. This contributes to optimized patient-ventilator synchrony while expanding access to personalized respiratory support for a particularly vulnerable patient population.”