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DOJ Announces Three Medtech-Related Enforcement Actions

 
• By Elizabeth Orr

The cases include brothers who operated a fraudulent telemedicine firm, a lab owner who reportedly billed for unnecessary COVID-19 tests, and a former device company employee who forged FDA clearance letters.

Justice (Michal Kalasek/Shutterstock.com)

Device-related violations are in the spotlight this week at the US Department of Justice, with the agency announcing guilty pleas in two medtech cases and filing charges in a third.

The first case, which was announced on 17 July, involved deceptive telemarketing of durable medical equipment and genetic testing to Medicare beneficiaries. Brothers Daniel Carver and Louis “Gino” Carver entered...

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State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.

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• By Elizabeth Orr

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• By Ashley Yeo

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Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

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