Sentec's LuMon Electrical Impedance Tomography System Gets FDA Clearance

Sept. 4, 2025 — Sentec recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its LuMon Electrical Impedance Tomography (EIT) system for premature infant, infant, adolescent and adult patients — making it the first EIT technology in the United States available for premature infants and for spontaneously breathing patients. 

While the LuMon System can be used to monitor a variety of patients, whether ventilated or spontaneously breathing, the premature infants and other patients in the NICU may stand to benefit the most from EIT's insights at the bedside.

"Neonatal patients present enormous complexity, especially for ventilation; there's very little room for error, particularly in our smallest patients – and the consequences can follow these babies all their lives," said Dr. David Tingay, Clinical Neonatologist and Respiratory Physiotherapist at Royal Children's Hospital in Melbourne, Australia.

Dr. Tingay has done extensive research with the LuMon EIT system in infant patients continued, "Without EIT, there's been no way for us to continuously see what is happening inside the lungs at the bedside to understand the impact of our interventions better as we perform them."

The ability to safely visualize lung function at the bedside, continuously and in real time, has enormous potential for guiding neonatal care and, according to Dr. Tingay, "EIT provides immediate imaging of regional lung function at the bedside. That visualization helps us better understand each patient's respiratory condition and determine the strategies we need to employ for their specific needs."

With the first-ever FDA clearance for premature infants and soft, fabric belts small enough for even very low birthweight infants, the LuMon™ System is positioned to help clinicians deliver gentle and effective respiratory care for the uniquely fragile and complex patients in the NICU.

While the basis of electrical impedance tomography and its use for imaging regional lung function has been present in research for many years, the LuMon™ system is first EIT technology available for routine clinical bedside use with premature infants in the United States, and can impact patient care and clinical decision making today.