Devices

Ex-Magellan Execs Plead Guilty in Device Scandal

Three former executives of Magellan Diagnostics have pleaded guilty to federal charges after concealing a medical device malfunction that led to inaccurately low lead test results for thousands of children and other patients.

Former CEO Amy Winslow, former chief operating officer Hossein Maleknia, and former quality assurance and regulatory affairs director Reba Daoust admitted to misleading customers and federal regulators about a defect in Magellan’s LeadCare testing devices, according to a Justice Department release. The devices, widely used to detect lead poisoning, failed to provide accurate results when testing venous blood samples and potentially put patients at risk, it says.

While the devices were generally effective for fingerstick tests, they failed to provide accurate readings for venous blood samples, a flaw that the executives concealed, the government contends. Federal prosecutors say the defendants deliberately misled FDA and Magellan’s customers about the severity and frequency of the device malfunction.

Now with their guilty pleas secured, the former executives await sentencing, which is expected to begin in June.

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