AngioDynamics Announces 510(k) Clearance For Celerity Tip Location System

(RTTNews) - AngioDynamics (ANGO) announced the U.S. FDA has granted the company 510(k) clearance for the Celerity tip location system, 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.

Joseph DeVivo, AngioDynamics' CEO, stated, "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. 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."