St. Jude Medical is disclosing new government scrutiny of its business.
In March, the Little Canada-based medical device maker received a Civil Investigative Demand from the U.S. Department of Justice. The government is seeking information about company communications related to insurance coverage of implantable defibrillators.
St. Jude disclosed the government inquiries in a securities filing. "The Company believes that similar requests were made of our major competitors. The Company is cooperating with the investigation and is continuing to work with the U.S. Department of Justice in responding to the CID," the filing said.
St. Jude also disclosed that in April, the FDA issued a warning letter citing the company for its marketing of two other devices used to treat malfunctioning heart tissue. One of the devices was already the subject of a Justice Department investigation.
"Customer orders have not been and are not expected to be impacted while the Company works to resolve the FDA's concerns," St. Jude said.
But St. Jude also says the government has been ramping up its scrutiny of the medical device industry, "and raising the threshold for compliance. The government is expected to continue to scrutinize the industry closely with inspections, and possibly enforcement actions, by the FDA or other agencies," St. Jude said.
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