Devices

FDA Criminal Probe Nets Device Maker Indictment

An FDA Office of Criminal Investigations probe has resulted in a 2/1 Puerto Rico federal grand jury indictment against Magnetic Healer and three individuals charging them with “conspiracy and introduction of adulterated and misbranded devices with intent to defraud and mislead, conspiracy to commit mail fraud, and alteration of a device after shipment in interstate commerce,” according to a Justice Department release.

The government says the defendants “unlawfully enriched themselves and operated the company Magnetic Healer of PR Inc. to sell devices containing magnets (healing magnets) which were advertised as being effective in the cure, mitigation, treatment, and prevention of diseases in humans, which included Covid-19, migraines, depression, insomnia, Parkinson’s disease, Alzheimer’s disease, autism, and cancer, among others.” The indictment also seeks a forfeiture totaling $327,000.

The government contends the devices were misbranded because they were not approved/cleared by FDA and their labeling was false and misleading, failed to include adequate directions for use, and lacked necessary warnings.

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