STATE COLLEGE, Pa.--(BUSINESS WIRE)--Today, Actuated Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) determined substantial equivalence of AMI’s TubeClear™ system specific to nasogastric (NG) feeding and decompression tubes.
TubeClear uses Actuated Medical’s proprietary mechanical motion technology to clear clogs in NG tubes. Clearing NG tubes prevents disruptions in feeding and medication delivery and allows clinicians to maintain their focus on improving patient care. The system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed, and manufactured by Actuated Medical in the United States.
Maureen L. Mulvihill, Ph.D., President of Actuated Medical, commented that, “Clogging is a significant problem occurring in approximately 25% of feeding and decompression tubes. Our TubeClear system has proven to be both fast and consistently effective. In fact, our studies show it to be at least seven times faster than current approaches. It allows caregivers to quickly reinstate feeding and medication regimens without removing and replacing tubes. In this new era of healthcare cost containment, it will certainly help organizations save significant time and money.”
In addition to the newly approved system for NG tubes, two new TubeClear control boxes as well as clearing tubes for Nasoenteric (nENT), Percutaneous Endoscopic Gastronomy (PEG) and Gastrostomy-Jejunostomy (GJ) tubes are currently pending 510(k) clearance with the FDA.
TubeClear is also CE Marked and is available throughout Europe, the Middle East and North Africa.
Actuated Medical is a medical device company that focuses on state-of-the-art, minimally invasive instruments for clearing occlusions, penetrating tissue, and enabling the emerging MRI-guided surgical procedure industry. A full-service company with U.S.-based design, development, and manufacturing, the company ultimately delivers enhanced clinical care and delivers improved patient outcomes. Actuated Medical is located in Bellefonte, PA and is certified ISO 13485:2003, 14971:2007 and WBE.