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Gravitas Medical received NEONATAL FDA 510(k) clearance for the Entarik system, which aids in the placement of feeding tubes and continuously monitors feeding tube position, gastric and esophageal temperature, and gastrointestinal impedance and reflux.

BERKELEY, Calif., Nov. 27, 2024 /PRNewswire-PRWeb/ -- Gravitas Medical, Inc. is pleased to announce that it received Neonatal 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance allows Gravitas Medical to market its revolutionary Entarik technology to the US neonatal population.

"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", says CEO Jorgen B Hansen. The Entarik System is designed for enteral feeding and to aid in the placement of the Entarik Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding. The Entarik System also continuously monitors feeding tube position, gastric and esophageal temperature, and gastrointestinal impedance and reflux.

The co-founder & CTO Saheel Sutaria continues: "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." He adds, "we would like to thank the visionary investigators at our clinical sites for their dedication to improving EN for neonates, as well as our hard-working team for making this happen."

About Gravitas Medical

Gravitas Medical Inc. is a Silicon Valley-based medical device company committed to revolutionizing enteral feeding into enteral nutrition intelligence. By harnessing the power of technology, Gravitas Medical transforms gut-related information into actionable insights for caregivers. This approach enables better decision-making, improved patient outcomes, reduced hospital stays, and a decreased overall cost of care.

Media Contact

Saheel Sutaria, Gravitas Medical, Inc., 1 6505166508, [email protected],  

SOURCE Gravitas Medical, Inc.