BELLEFONTE, Pa.--(EON: Enhanced Online News)--Today, Actuated Medical, Inc. announced the addition of several new Clearing Stem models for its TubeClear® system. The US Food and Drug Administration (FDA) determined substantial equivalence of these models specific to nasoenteral (NE), gastrostomy (G), and jejunostomy (J) feeding and decompression tubes. This expands the FDA’s previous determination for nasogastric (NG) tubes in July 2012.
TubeClear uses Actuated Medical's proprietary mechanical motion technology to clear clogs in feeding and decompression tubes without the discomfort and expense of removing them from the patient. This has the combined benefit of reducing disruptions in patient feeding and medication delivery while providing substantial cost savings for the institution.
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. With this latest FDA clearance the financial case becomes exceptionally strong. Using typical costs for clearing G and J tubes, our ROI Calculator shows annual savings of $243,000 for a typical 500-bed facility. With the current focus on healthcare cost containment, this provides a significant impact on the bottom line for just about any institution.”
The TubeClear 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. In addition to having FDA clearance, TubeClear is CE Marked and is available throughout the United States, 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 firm with U.S.-based design, development, and manufacturing, the company ultimately enhances clinical care and delivers positive patient outcomes. Actuated Medical is located in Bellefonte, PA and is certified ISO 13485:2003, 14971:2007 and Women’s Business Enterprise (WBE).