Sentec has received the US Food and Drug Administration (FDA) 510(k) clearance for its LuMon electrical impedance tomography (EIT) system for use in premature infants and spontaneously breathing patients.
The LuMon system is designed to provide functional lung imaging directly at the patient’s bedside without the need for radiation.
According to Sentec, the technology empowers clinicians to customise therapy for each patient’s requirements, particularly benefiting those in neonatal intensive care units (NICUs).
It supports NICU clinicians by offering small, fabric belts suitable for low birthweight infants, enabling gentle and effective respiratory care for vulnerable patients.
The system aims to transform bedside monitoring by providing immediate insights to personalise ventilatory care in premature infants.
Sentec stated that LuMon is the first EIT technology approved in the US and represents an advancement in non-invasive patient monitoring.
Royal Children’s Hospital clinical neonatologist and respiratory physiotherapist David Tingay said: “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.
“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 electrical impedance tomography procedure involves transmission of gentle, alternating currents through the thorax using a comfortable fabric belt.
The process captures dynamic images showing regional impedance changes from breathing, enabling assessment of real-time responses to ventilation adjustments.
The LuMon system, tailored for critical care settings, supports neonates, paediatric, and adult patients by monitoring regional impedance variations in the thorax.
The capability enhances the assessment of air distribution and lung recruitment, facilitating timely interventions that could improve patient outcomes, said Sentec.
