Devices

Alere Paying $38.75 Million for False Claims Allegations

Alere Inc. and its Alere San Diego subsidiary will pay $38.75 million to resolve federal government allegations that they violated the False Claims Act by billing Medicare for defective rapid point-of-care testing devices. A Department of Justice statement says the government alleges that between 2008 and 2018 the companies knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries taking anticoagulant drugs. For such patients, the department says, monitoring is essential to determining a clinically appropriate and safe dosage for their medications.

The government says Alere allegedly knew that the software algorithm used in each version of the monitors contained a material defect. “Based on its own internal research, as well as external complaints and warnings, Alere allegedly knew that INRatio devices had a ‘system limitation’ that produced inaccurate and unreliable results for some patients,” the statement says.

The government says the monitors were linked to over a dozen deaths and hundreds of injuries. The company allegedly failed to take appropriate corrective actions until 2016, when the devices were removed from the market following a nationwide Class 1 product recall undertaken at the request of FDA, it says.

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