Gravitas Medical Announces US FDA Clearance of the Entarik Platform
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.”
“We are thrilled to bring this innovative new product to market”, said Jim Gabalski, Vice President 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.”
Gravitas Medical will be attending the American Society for Parenteral and Enteral Nutrition (ASPEN) Conference in Las Vegas on April 20-23, 2023 where interested Enteral Nutrition professionals will be able to get a first look at Entarik.
About Gravitas Medical
Gravitas Medical is a Silicon Valley-based medical device company that emerged out of Theranova, a MedTech incubator focused on tackling the biggest challenges in healthcare. Gravitas Medical is focused on transforming enteral feeding into enteral nutrition intelligence. The gut provides information and Gravitas uses use its passion for technology to find new ways to gather that information and provide it to caregivers so that they can make better decisions, improve outcomes for their patients, reduce the amount of time a patient stays in the hospital, and reduce the overall cost of care. They take the guesswork out of enteral nutrition.
Source: https://www.prweb.com/releases/2023/3/prweb19249262.htm
