Medical device company Gravitas Medical has received a second US Food and Drug Administration (FDA) Neonatal 510(k) clearance for its Entarik System.
This approval allows the company to market its Entarik technology to the US neonatal market.
The Entarik System is designed for neonatal enteral feeding. It aids in placing the Entarik Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding.
The system also continuously monitors feeding tube position, gastric and oesophageal temperature, and gastrointestinal impedance and reflux.
The first FDA clearance was received in March 2023. In December last year, the system earned a second FDA’s Breakthrough Device Designation.
Gravitas Medical CEO Jorgen B Hansen said: “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.”
The system is also being developed for placing the Gravitas Enteral Feeding Tube into the stomach of child, and adolescent patients who require enteral feeding.
Equipped with sensors, the Gravitas Feeding Tube helps determine the tube tip’s location, reducing misplacement during initial positioning and continuously monitoring for dislodgement.
The Gravitas Pediatric Feeding Tube is intended for administering nutrition, fluids, and medications via the nasoenteric route to paediatric patients with an intact gastrointestinal tract who are unable to manage normal nutritional intake.
Gravitas Medical co-founder and chief technology officer Saheel Sutaria said: “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.
“In addition, with clearance in neonates and adults, we can now build out a full portfolio for all ages in between.”
Gravitas Medical, a spin-off from San Francisco-based Theranova. The company focuses on enteral feeding into enteral nutrition intelligence.
By leveraging advanced technology, the medical device firm converts gut-related data into actionable insights for caregivers. This approach leads to better decision-making, improved patient outcomes, shorter hospital stays, and reduced healthcare costs.
