FDA Grants Breakthrough Device Designation to Gravitas Medical for Neonatal Patients Requiring Enteral Feeding

Gravitas Medical announces U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Entarik, the innovative Gravitas Feeding Tube System.

SAN FRANCISCO, Sept. 26, 2023 /PRNewswire-PRWeb/ -- Gravitas Medical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Entarik, the innovative Gravitas Feeding Tube System. This milestone signifies a major step forward in advancing neonatal healthcare by providing expedited access to this revolutionary technology for patients in need.

The FDA's Breakthrough Device Program is designed to streamline the development, assessment, and review process, ensuring that groundbreaking medical devices swiftly reach patients.

Gravitas Medical's Pioneering Solution

Entarik is designed to aid, in conjunction with institutional protocols, qualified operators (medical professionals) in the placement of the Gravitas Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding. The Gravitas Feeding Tube is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, assisting in reducing the incidence of misplacement during first positioning. The Gravitas Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake normally.

Jorgen Hansen, CEO of Gravitas Medical, expressed enthusiasm about the Breakthrough Device designation, stating, "The Breakthrough Device designation promises to accelerate the introduction of Entarik for neonatal patients." Gravitas Medical previously received FDA approval for adult use of the Entarik platform in March 2023. Hansen added, "Expanding the use of Entarik to neonatal patients is one of our top priorities because these patients urgently require access to enteral feeding to facilitate the best possible outcomes."

The Breakthrough Device Program's Impact

The Breakthrough Devices Program requires meeting well defined criteria. Gravitas Medical's achievement of the Breakthrough Device Designation validates its potential to enhance the treatment or diagnosis of life-threatening or irreversibly debilitating medical conditions and establishes that no approved alternatives exist. The program's benefits include expediting device development, prioritizing subsequent regulatory submissions, and potentially provides for faster reimbursement after clearance .

"We remain focused on rapidly expanding the Entarik platform to include use with neonatal patients," concluded Hansen.

About Gravitas Medical

Gravitas Medical 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. Gravitas Medical emerged from Theranova, a MedTech incubator focused on addressing the most pressing challenges in healthcare.

Media Contact

Jim Gabalski, Gravitas Medical, 1 5853505468, [email protected], www.gravitasmedinc.com

SOURCE Gravitas Medical