AngioDynamics has announced obtaining 510(k) clearance for the Celerity tip location system from the US Food and Drug Administration (FDA). The Celerity system has been cleared by the FDA as an adjunct to aid in positioning Peripherally Inserted Central Catheters (PICCs) in adults by providing real time catheter tip location utilising the patient’s cardiac electrical activity.
The company expects to begin US distribution in early July. In March, AngioDynamics announced an agreement to acquire regulatory control over the Celerity platform from its business partner, Medcomp, and its development partner, after the FDA rejected Medcomp’s initial 510(k) application.
“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,” said Joseph M DeVivo, AngioDynamics’ president and CEO.
“Celerity’s FDA clearance marks a milestone in the development of AngioDynamics’ Vascular Access Business,” added Chuck Greiner, senior vice president of AngioDynamics’ Vascular Access Business. “The Celerity tip location system, coupled with our thromboresistant BioFlo PICCs, positions us to provide an unparalleled product offering to our customers. At a time when our innovative BioFlo platform has already led the business to returned growth, Celerity is poised to strengthen those gains.”