Gravitas Medical Inc., a Silicon Valley-based medical device company, has announced its second FDA clearance for the Entarik system, an enteral nutrition delivery system now cleared for use in neonates. This clearance positions the Entarik system as the only smart enteral nutrition solution with continuous monitoring capabilities for this vulnerable population.
The Entarik system addresses critical challenges in neonatal enteral nutrition, where feeding tubes are often placed without direct visualization, and radiation exposure from X-rays is minimized when possible. This often leads to underfeeding due to a lack of real-time data on nutrient absorption and tolerance. The Entarik system's continuous monitoring aims to provide clinicians with actionable insights to optimize feeding strategies and improve patient outcomes.
"We are extremely pleased to announce that Gravitas Medical now has the ONLY smart enteral nutrition delivery system cleared for neonates and the ONLY EN solution with continuous monitoring," said Jorgen B Hansen, CEO of Gravitas Medical.
Saheel Sutaria, co-founder & CTO, added, "This is a huge milestone that will allow us to improve care in a vulnerable population where feeding tubes are essentially placed blind since x-ray radiation is avoided if possible, and many babies are underfed due to a lack of data."
With FDA clearance for both neonates and adults, Gravitas Medical intends to develop a comprehensive portfolio of enteral nutrition solutions for all age groups. The company's focus is on transforming enteral feeding into enteral nutrition intelligence by leveraging technology to provide caregivers with gut-related information for better decision-making, improved patient outcomes, reduced hospital stays, and decreased overall cost of care.
