Devices

Man Pleads Guilty to Selling Used Medical Devices

Kambiz Youabian (Tarzana, CA) has pleaded guilty to a two-count information charging him with mail fraud and introducing misbranded medical devices into interstate commerce. The government says Youabian operated an almost $6 million scheme in which he knowingly sold used skin-tightening medical devices that were deliberately misbranded as new, as well as counterfeit devices that he claimed were to be used with fat-reducing laser machines.

Youabian owned and operated MSY Technologies Inc., which did business under the names “Thermagen” and “Global Electronic Supplies,” according to a Justice Department release. From 3/2016 to 6/2022, Youabian purchased used and depleted transducers, devices that are used to tighten the skin of dermatology patients by delivering ultrasound energy to their skin. He remanufactured the depleted transducers and added fabricated serial numbers to make them appear to be new, the government contends.

Youabian admitted in his plea agreement to unlawfully selling thousands of medical devices, and receiving almost $6 million in fraudulent proceeds that should have been paid to the companies that are the sole U.S. distributors for these devices, the government says. He is scheduled for a 6/26 sentencing hearing and faces up to 23 years in federal 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