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AngioDynamics Addresses FDA Warning for NanoKnife System

AngioDynamics Inc.ANGO recently announced resolution of the FDA warning letter that the company had received for its NanoKnife System. Notably, in Jan 2011, AngioDynamics was warned by the FDA regarding a few aspects of its marketing program for the NanoKnife System.

The FDA warning letter notified that AngioDynamics was trying to promote the use of the NanoKnife System outside its cleared indications at that point of time. However, over the last four years, AngioDynamics has worked thoroughly to address the issue.

Per management, AngioDynamics has improved its quality and conformity systems, which include product design, manufacturing process as well as marketing of the NanoKnife System. We believe that the recent settlement will act as a significant booster for the company's NanoKnife line of products.

We believe that following the resolution of the FDA warning letter, more number of hospitals will be interested in adopting the NanoKnife System, which in turn, will boost sales. AngioDynamics is quite focused on expanding the reach of its NanoKnife system, reflected by the recent product approval in four Asian countries - South Korea, Malaysia, Thailand and Vietnam.

The approvals came close on the heels of AngioDynamics' receipt of Certificates to Foreign Governments (CFGs) for NanoKnife from the FDA in its fiscal fourth-quarter 2015. NanoKnife has already been approved across 45 countries. In the U.S., the system has received a 510(k) clearance from the FDA for use in the surgical ablation of soft tissue. It is also commercially approved in Canada, the European Union and Australia.

AngioDynamics continues to enjoy healthy demand for its coveted NanoKnife system. Increasing international penetration of the device will contribute to revenues at the company's Oncology division. Management also believes that a possible increase in reimbursement rates for NanoKnife will boost U.S. revenues in fiscal 2016.

Zacks Rank and Key Picks

Currently, AngioDynamics carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical space are Intuitive Surgical ISRG , Natus Medical BABY and Masimo MASI . While Masimp and Natus Medical sport a Zacks Rank #1 (Strong Buy), Intuitive Surgical carries a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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