Gravitas Medical this week announced it received FDA 510(k) clearance for its Enteric feeding tube system and feeding tube.
The Enteral nutrition delivery system has a “smart” nasogastric tube that is equipped with sensors to provide information about the location of the tube tip relative to the stomach and monitor. Together, the sensors and the monitor continuously track the position of the tube during the course of feeding.
“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,” CEO Sahel Sutaria said in a news release.
According to the company, the system assists in reducing the incidence of misplacement during the 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.”
“We are thrilled to bring this innovative new product to market”, said Jim Gabalski, VP of marketing and sales. “The use of enteral feeding is rising as hospitals care for an increasing number of patients with head and neck cancer, stroke, and other conditions that inhibit normal food intake. Entarik provides an easy-to-use platform that will expand in capability to provide ICU teams with timely information, enabling better decisions, improved outcomes, and shorter lengths of stay.”