Devices

2nd Fraudulent Medical Device Guilty Plea

The Department of Justice (DoJ) says a second individual has pleaded guilty in connection with a scheme to defraud consumers by selling laser devices as a treatment for more than 200 different diseases and disorders. A department news statement says Irina Kossovskaia, of Ontario, Canada, pleaded guilty in South Dakota federal court to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead. Ronald Weir pleaded guilty to his role in the conspiracy 2/2017. Charges are pending against two other individuals relating to their involvement with the “QLaser System.”

Government documents say the four marketed and distributed the devices by falsely claiming that they could safely and effectively treat many medical conditions at home including cancer, diabetes, autism, HIV, and heart disease. “No published clinical or scientific studies supported the use of QLaser devices to treat such serious conditions,” DoJ says, “and FDA never approved the devices for such use.”

In addition to fines, Kossovskaia faces a maximum statutory sentence of five years in prison.

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