Devices

Medical Device Company Sentenced to Pay $42 Million

The Department of Justice says Magellan Diagnostics, headquartered in Billerica, MA, was sentenced in a Massachusetts federal court on 10/9 for criminal charges related to concealing a device malfunction that produced inaccurately low lead test results. A department statement says the company pleaded guilty to two counts of introducing a misbranded medical device into interstate commerce and was ordered to pay a $21.8 million fine, $10.9 million in forfeiture, and a minimum of $9.3 million to compensate patient victims.

Court documents indicate Magellan failed to timely notify FDA about a serious malfunction that caused its LeadCare devices to produce inaccurate blood test level results, the statement says. Magellan also reportedly changed the user instructions for the devices without prior agency notice or approval.

FDA ultimately determined that the LeadCare devices could not accurately test venous samples, leading to a recall of all the devices using venous samples and a warning to the public not to use LeadCare Ultra, LeadCare II, or LeadCare Plus for testing venous blood samples because of the malfunction and a recommendation that doctors retest certain patients, according to the Justice Department.

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