In August 2012, when Keystone Edge last checked in with Actuated Medical, the Bellefonte company had just gotten FDA clearance to begin U.S. sales of its TubeClear medical device.
Not resting on its laurels, the company has now received additional FDA clearance for its expanded line, is preparing to launch a new product and continues to grow its workforce.
President Maureen Mulvihill reports that latest FDA clearance “expands our market significantly.” TubeClear is a device that removes clogs in medical feeding and decompression tubes without the discomfort and expense of detaching them from the patient. The new FDA clearance gives the green light to new models that are of particular use with chronically ill patients in long-term care with diseases such as Alzheimer's, Parkinson's or cancer, says Mulvihill.
The system can provide annual savings of $243,000 for a typical 500-bed facility, she adds, and Actuated has recently signed with a large hospital system and is in process with another.
Actuated is also preparing for the January launch of an altogether new product, General Sharp, for low-force insertion of lancets and needles for more humane blood sampling. And the company expects to go back to the FDA again in 2014 with additional models of TubeClear to enable further applications.
All of this activity means scaled-up manufacturing in Bellefonte. The company just hired a director of manufacturing — its workforce now stands at 24, up from 17 last August – and Mulvihill anticipates continued job creation.
Source: Maureen Mulvihill, Actuated Medical
Writer: Elise Vider