FDA OKs Sentec’s LuMon Electrical Impedance Tomography System

Sentec, a company specializing in non-invasive patient monitoring, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its LuMon electrical impedance tomography (EIT) system for premature infant, infant, adolescent, and adult patients.

The company hails LuMon as the first EIT technology in the U.S. available for premature infants and for spontaneously breathing patients. The system provides functional lung imaging at the bedside, without radiation.

Sentec said LuMon can be used to monitor a variety of patients both ventilated or spontaneous breathing, but the premature infants and other NICU patients could stand to benefit the most from EIT’s insights at the bedside.

Dr. David Tingay, a clinical neonatologist and respiratory physiotherapist at Royal Children’s Hospital in Melbourne, Australia, said neonatal patients present a huge complexity, especially for ventilation—there’s very little room for error in the smallest patients. The consequences can follow the babies all their lives.

Dr. Tingay has done extensive research with the LuMon EIT system in infant patients: “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,” he told the press.

The system’s fabric belts are small enough for very low birthweight infants, Sentec also said.