Devices

Carefusion Paying $3.3 Million For Fraud Charges

The Justice Department and CDRH director Jeffrey Shuren say Carefusion Corp., San Diego, CA, will pay $3.3 million to the federal government to resolve charges that it bought and sold medical devices that were not cleared or approved by FDA. A Justice Department statement says the unapproved devices were used by healthcare providers in medical procedures and the providers then submitted claims for reimbursement to federal healthcare programs for the procedures. The charges were brought under the False Claims Act.

Of the $3.3 million Carefusion agreed to pay as part of a settlement approved 5/7 by a New York federal judge, $2.8 million will go to the U.S. and $478 460.08 will go to states adversely affected by Carefusion’s conduct through separate settlements with those states.

In connection with the settlement, the federal government joined a private whistleblower lawsuit that had previously been filed under seal under the False Claims Act. The statement says that suit remains under seal as the government continues its investigation.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome