FDA clearance for Celerity tip location medical device system

FDA clearance for Celerity tip location medical device system

Celerity is an adjunct to aid in positioning peripherally inserted central catheters in adults, providing real-time catheter tip location.

June 28, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations

Albany, New York – AngioDynamics officials announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Celerity tip location system.

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 utilizing the patient's cardiac electrical activity. The company expects to begin U.S. distribution in early July. In March, AngioDynamics announced an agreement 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.

"We committed ourselves to establishing a clear regulatory pathway to bring Celerity to the U.S. market by mid-summer and this first 510(k) Clearance places us squarely on that timeline," said Joseph M. DeVivo, AngioDynamics' president and chief executive officer. "Not only does this clearance highlight the expertise of our regulatory affairs team, it is the first step in a long-term strategy that includes bringing next generation devices with navigation capabilities to market."

"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."

Source: AngioDynamics