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.
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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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.
Related Articles on Medical Devices:
KSpine Raises $2.5M for Spinal Implant to Treat Scoliosis
FDA Targets Risks From Reused Medical Devices
Novus Scientific Receives New U.S. Patent for Mesh Implant