The FDA has approved the Celerity tip location system as an adjunct to help in positioning peripherally inserted central catheters in adults by providing real time catheter tip location utilizing the patient’s cardiac electrical activity.
AngioDynamics plans to initiate distribution of the Celerity tip location system in the US in July 2014.
AngioDynamics president and CEO Joseph DeVivo said: "We committed ourselves to establishing a clear regulatory pathway to bring Celerity to the US market by mid-summer and this first 510(k) clearance places us squarely on that timeline."
AngioDynamics Vascular Access business senior vice president Chuck Greiner said that the Celerity tip location system, coupled with the company’s thromboresistant BioFlo PICCs, positions it to provide an unparalleled product offering to its customers.
"At a time when our innovative BioFlo platform has already led the business to returned growth, Celerity is poised to strengthen those gains," Greiner added.
AngioDynamics reached an agreement in March 2014 to acquire regulatory control over the Celerity platform from the company’s business partner, Medcomp, and its development partner, after the FDA rejected Medcomp’s initial 510(k) application.
