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news.ATS Medical has received ISO certification for its Quality System to manufacture and CE Mark approval to distribute ATS CryoMaze cardiac ablation products in the EU, indicating it is in compliance with relevant European health, safety and environmental protection legislation.
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These approvals, in combination with the completion of transfer of the US 510k rights and validation of the manufacturing processes, enable the company to sell the ATS-manufactured product line into the US and Europe.
The regulatory approvals are the final step in the integration of the surgical ablation business, which the company acquired in June 2007.
Michael Dale, president and CEO of ATS Medical, said: “We are extremely pleased with the market’s acceptance of our ATS CryoMaze products and believe this business will be a primary contributor to the acceleration of revenue growth over the next several years.
“With the integration process behind us, we are now able to focus our efforts on manufacturing process improvements and cost reductions and have the flexibility to develop new products on a reduced timeline.”