Devices

2 Former Arriva Execs Settling False Claims Act Charges

Two former Arriva Medical executives will each pay $500,000 to settle False Claims Act charges that they caused the company to submit false claims to Medicare that were tainted by kickbacks paid to beneficiaries in the form of free or no-cost home blood glucose meters or waived or uncollected copayments from 11/23/11through 8/30/13. A Department of Justice media statement identified the executives as former Arriva president David Wallace and former vice president Timothy Stocksdale.

The settlement also resolves the federal government’s claim that Wallace and Stocksdale caused the diabetic testing supply company to bill Medicare for medically unnecessary home blood glucose meters during the same period.

The Justice Department says that on 2/8, the United States separately intervened in a False Claims Act case alleging that Arriva and medical device company Alere submitted and/or caused to be submitted false claims to the Medicare program for medically unnecessary glucometers and diabetic testing supplies that were tainted by kickbacks. Both Arriva and Alere were acquired by Abbott 9/2017.

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