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Legal & Regulatory Issues

The Food and Drug Administration may toughen is approval process for 510(k) clearance for medical devices, according to a report by the Wall Street Journal. The move causes concern for medical device makers who worry that tightened approval processes could…

Cameron J. Justice of Crum, W.Va., owner and president of Justice Medical Complex, with conspiracy to misuse a physicians registration number and aiding and abetting healthcare fraud, according to a report in The Charleston Gazette.

The FDA unveiled an initiative to reduce unnecessary radiation exposure from CT scans, nuclear medicine studies and fluoroscopy, the three procedures that are the greatest contributors to radiation exposure in the U.S., according to an FDA press release.

The Department of Health and Human Services' Office of the Inspector General released its Justification of Estimates for Appropriations Committees report for fiscal year 2011 proposed budget, which included a $40 million increase to continue to support and increase efforts…

In what may be an unprecedented prosecution, Anne Mitchell was scheduled to stand trial Feb. 8 in a Texas court for "misuse of official information," a third-degree felony charge, after reporting a physician last April to the Texas Medical Board…

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Teva Pharmaceutical Industries will take a $315 million charge in its fourth quarter in connection with a settlement to resolve a drug-pricing lawsuit brought by Ven-A-Care of the Florida Keys against several of the company's U.S. subsidiaries, according to a…

Rep. Betsy Markey (D-Colo.) and Rep. Tom Perriello (D-Va.) will introduce legislation to repeal the special anti-trust exemption for health insurance and medical malpractice insurance companies, according to a news release by Rep. Markey's office.

Southern New Hampshire Medical Center agreed to pay a $33,400 civil settlement to resolve allegations that it violated the federal False Claims Act by submitting bills to federal healthcare programs for a nursing assistant who had been excluded from these…

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