Four years in development, and 10 months before the Food and Drug Administration,
, a new medical device developed and manufactured in Bellefonte has won FDA clearance for U.S. sales.
Maureen Mulvihill, president of Actuated Medical
, says the product is the first that the company has brought to market.
TubeClear removes clogs in medical feeding and decompression tubes using reusable control boxes and single-use cleaning stems that mechanically clear clogs without the need to remove and replace the tube and with minimal disruption in the delivery of nutrition and medication.
With FDA approval, a domestic distribution deal in the works and a distribution agreement in place for Europe, the Middle East and North Africa, Actuated has added four new positions to produce TubeClear. The company now has 17 employees total, Mulvihill says, including its research and development team, which has more products in the pipeline, including surgical devices.
Actuated was founded in 2006 as Piezo Resonance Innovations, drawing on a physics term. Last year, the company became Actuated Medical, which means motion in medicine. "We wanted a name that describes what we do," says Mulvihill.
Having cleared its first commercialization hurdle and attracting capital from private investors, "it all looks positive" for Actuated, says Mulvihill, who expects to add jobs as the company grows. But she worries about drastic cutbacks in federal research grants to small business, which were critical in getting Actuated to this point. "If this had happened four years ago to us, we wouldn't be in this situation," she adds.
Source: Maureen Mulvihill, Actuated Medical
Writer: Elise Vider