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News

FDA clearance on anti-clogging feeding tubes

Actuated Medical : 27 September, 2013  (New Product)
The TubeClear system for clinical feeding with reduced incidence of clogging has been approved by the FDA
FDA clearance on anti-clogging feeding tubes


Actuated Medical has 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 Mulvihill, PhD, 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.


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