Gravitas Medical Inc. has received FDA clearance of its innovative Entarik Feeding Tube System and Feeding Tube. This new System includes a sensor-based nasogastric tube and monitor. Entarik provides enteral nutrition intelligence to caregivers enabling timely decision making for patients with feeding tubes, helping to avoid complications and improve outcomes.
Gravitas Medical today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its innovative Entarik Feeding Tube System and Feeding Tube. This innovative enteral nutrition delivery system is set to be the first of many products that Gravitas will introduce that will transform enteral feeding into enteral intelligence. “Our mission is to use technology to replace the current nutrition delivery solutions with an enteral nutrition intelligence platform that helps caregivers make timely decisions for their patients, and this marks the beginning of that transformation,” said Saheel Sutaria, CEO of Gravitas Medical.
The system consists of a “smart” nasogastric tube equipped with sensors designed to provide information about the location of the tube tip relative to the stomach and a monitor that continuously monitors the position of the tube during the course of feeding. The system assists in reducing the incidence of misplacement during first positioning and provides real-time alerts of tube migration. “There is risk to the patient when a feeding tube migrates from the stomach to the esophagus,” said Sutaria. “The Entarik System is designed to provide an alert when a nasogastric tube migrates so that ICU clinical staff can make timely decisions that assist in avoiding complications.”