FDA Bans Oridion Systems From Importing Medical Devices Into the U.S.

The FDA banned Israeli medical device company Oridion Systems from importing its patient monitoring medical devices into the U.S., according to a Market Watch report.

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Last October, Oridion received a warning letter from the FDA about procedures to ensure that its products conform to specified requirements. Although the company says it made efforts to correct the issues, the bar occurred last week. Fourth-quarter growth will be “minimal” and full-year revenue is expected to increase 17 percent instead of the previously expected 20 percent, the company said.

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