Gravitas Medical has garnered a second U.S. Food and Drug Administration (FDA) 510(k) clearance for its Entarik technology for neonatal patients.
“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,” Gravitas Medical CEO Jorgen B. Hansen said.
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The Entarik System is designed for enteral feeding and to help place the Entarik Enteral Feeding Tube into neonatal patients’ stomachs for feeding. The Entarik System also continuously monitors feeding tube position, gastric and esophageal temperature, and gastrointestinal impedance and reflux.
“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,” Gravitas Medical Co-Founder/Chief Technology Officer Saheel Sutaria stated. “In addition, with clearance in neonates and adults, we can now build out a full portfolio for all ages in between. We would like to thank the investigators at our clinical sites for their dedication to improving EN for neonates, as well as our team for making this happen.”
Gravitas Medical Inc. is a Silicon Valley-based medical device company committed to improving 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 decreased overall care costs.
