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June 17, 2014
FDA Clears AngioDynamics' Celerity Tip Location System
June 18, 2014—AngioDynamics announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Celerity tip location system as an adjunct to aid in positioning peripherally inserted central catheters in adults. The Celerity system provides real-time catheter tip location by using the patient’s cardiac electrical activity.
AngioDynamics expects to begin distribution in the United States in early July. The company has been marketing the Celerity device, as well as the thromboresistant BioFlo peripherally inserted central catheter, in Canada.
In March, AngioDynamics announced an agreement to acquire regulatory control over the Celerity platform—and exclusive rights to a next-generation system that includes navigation capabilities—from the company's business partner, Medcomp Inc., after the FDA rejected Medcomp’s initial 510(k) application. At that time, AngioDynamics determined that the FDA’s decision resulted from the execution of a human factors study rather than the device itself. Following discussions with the agency, those issues were addressed in a subsequent filing, advised the company.
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