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Two companies cited for use of unapproved medical devices

Although unrelated cases, both create worry within the medical community

In separate incidents, two medical device manufacturers are in the spotlight for having doctors use their equipment despite it not having FDA approval.

According to the Associated Press, Medtronics is settling a case with the U.S Justice Department on allegations they paid doctors to an unapproved use of its neuro-stimilation device, which was not approved by the FDA.

They will pay the #2.8 million to settle the allegations.

Not related to the Medtronics case, OtisMed was the subject of a recent New York Times feature that told the story of another medical device that was used during a knee replacement surgery, but was not approved by the FDA.

"As it turned out, the OtisMed Corporation, the maker of the OtisKnee, did not seek clearance from the Food and Drug Administration for its OtisKnee guides before it started selling them," according to the New York Times' article. "When the company did apply for F.D.A. review, its application was rejected because, the agency said, the company failed to show that the product was safe and effective."

According to the article, the company and its former chief executive pleaded guilty in December to "criminal charges of distributing adulterated medical devices."

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