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Surge In US Enforcement Actions Shows Focus On Diagnostics

 
• By Elizabeth Orr

An apparent spike in health care enforcement actions by the US Department of Justice has led to hundreds of millions of dollars in penalties and multiple jail sentences throughout the sector. The DOJ has announced at least 20 device-related cases since mid-September.

The northern facade of the Department of Justice building in Washington, DC.
• Source: Shutterstock

Diagnostic firm Genomics Health, a subsidiary of Exact Sciences Corp. , agreed to pay $32.5m to resolve allegations it had filed Medicare claims for some cancer tests. A North Carolina lab owner was sentenced to almost 17 years in prison for billing Medicaid for unnecessary drug tests for Medicaid beneficiaries. And at least 10 practitioners are facing jail time or massive fines for violations of the False Claims Act.

That’s just a sliver of the health care fraud cases announced by the US Department of Justice over the last...

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Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Global Medtech Guidance Tracker: June 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By Elizabeth Orr

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By Marion Webb

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

More from Policy & Regulation

Global Medtech Guidance Tracker: June 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
• By Amanda Maxwell

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.