Subject: FDA
Gravitas Medical Inc. Announces SECOND FDA Breakthrough Device Designation for its Entarik System; Pediatric Patients to Benefit from Enteral Nutrition Innovation!
Gravitas Medical to accelerate development and approval processes to expedite pediatric patient access to Entarik's revolutionary technology.
SAN FRANCISCO, Dec. 13, 2023 /PRNewswire-PRWeb/ -- Gravitas Medical Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a second Breakthrough Device Designation to Entarik, the innovative Enteral Feeding System. This award allows Gravitas Medical to accelerate development and approval processes to expedite pediatric patient access to Entarik's revolutionary technology.
Gravitas Medical Pioneers Pediatric Enteral Nutrition Advancement
"Since 2016, only eight (8) medical device manufacturers have been granted multiple Breakthrough Designations and only one of those in the same year", said Jorgen B. Hansen, CEO of Gravitas Medical. "This second designation recognizes the lifesaving potential of Entarik for pediatric and adolescent patients in addition to neonates." Gravitas Medical previously received FDA approval for adult use of the Entarik platform in March 2023 and Breakthrough Designation for neonates in September 2023. Hansen added, "Entarik will reduce the amount of time pediatric, neonatal, and adult patients spend in intensive care. Reducing lengths of stay and improving patient outcomes is our focus."
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 infant, child, and adolescent 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 while continuously monitoring for tube dislodgement. The Gravitas Pediatric Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for pediatric patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake normally.
Breakthrough Device Designation is Difficult to Earn
Breakthrough Device Designation is difficult to achieve, and Gravitas Medical's Entarik Feeding System has earned two (2) of the 109 designations reported for 2023 on the FDA website. To earn Breakthrough Designation, a device must demonstrate potential to enhance the treatment or diagnosis of life-threatening or irreversibly debilitating medical conditions and no approved alternatives can exist. The Breakthrough Device program's benefits include expediting device development, prioritizing subsequent regulatory submissions, and potentially provides for faster reimbursement after clearance.
"This second Breakthrough Designation recognizes the importance of the Gravitas Medical team's work and Entarik's potential to save lives of pediatric patients," concluded Hansen.
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
Jim Gabalski, Gravitas Medical Inc., 1 585.350.5468, [email protected], https://www.gravitasmedinc.com/
SOURCE Gravitas Medical Inc.
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