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AngioDynamics lands FDA win, takes over 510(k) process for rejected Medcomp

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AngioDynamnics lands FDA win, takes over 510(k) process for Medcomp

Medical device maker AngioDynamics (NSDQ:ANGO) announced progress in its regulatory efforts, landing FDA clearance for the latest in its BioFlo vascular access line and taking over 510(k) efforts for Medcomp’s Celerity tip location system.

AngioDynamics touted 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter, now the 3rd in the company’s portfolio of FDA-cleared BioFlo products. AngioDynamics expects commercial launch during its 4th quarter of 2014, according to a company statement.

The New York medtech maker also took over FDA efforts for the Celerity tip location technology, which is owned by distribution partner Medcomp. The Celerity system was just rejected by the FDA, but AngioDynamics believes it can apply a little finesse and get the application back on track.

"AngioDynamics has determined the Agency’s decision resulted from the execution of a human factors study rather than the device itself," according to a press release. "Following discussions with the Agency, AngioDynamics believes it can fully address these issues in a subsequent filing, which it expects to be submitted in early April."

Medcomp agreed to give AngioDynamics regulatory control of Celerity as well as exclusive rights to the next generation of the technology, which goes hand-in-hand with certain BioFlo devices. AngioDynamics already sells the Celerity system in Canada.

ANGO shares were pretty flat today, dropping 0.3% to $15.55 as of about 12:15 p.m. The stock has lost more than 10% since the start of the year.

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