Attune Medical said today that it won 510(k) clearance from the FDA for a new model of its EnsoETM device capable of administering tube feeds or medication while regulating a patient’s temperature through the esophagus.
The newly-approved model allows clinicians to maintain a patient’s core temperature while simultaneously administering fluids, eliminating the need for a separate feeding tube.
“Attune Medical is focused on developing innovative targeted temperature management products with increasingly useful clinical features such as this new capability to administer tube feeds and medication through our device, all while delivering a safe, cost-effective and now more comprehensive alternative to other targeted temperature management options,” CEO Keith Warner said in prepared remarks.
“The new EnsoETM with EnFit connection will offer customers a seamless way to adhere to increasing worldwide standardization toward a fail-safe approach to interfacing patients with feeding and medicinal support designed to prevent tubal misconnection,” Attune’s VP of clinical services, Maria Gray, added.
