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FDA Panel To Address Paclitaxel Safety Concerns

 
• By Elizabeth Orr

The US FDA will soon hold a meeting to discuss paclitaxel-coated devices to treat peripheral arterial disease. The drug-eluting stents and balloons have been subject to increased scrutiny since a meta-analysis found they were linked to a higher patient mortality rate.

FDA Advisory Committee Feature image

The increased scrutiny of paclitaxel-coated devices to treat peripheral arterial disease (PAD) will continue with an upcoming meeting of the US FDA’s coronary devices advisory panel.

The meeting, which the FDA announced in the April 22 Federal Register, will be held in Gaithersburg, Maryland on June...

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More from United States

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By Elizabeth Orr

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• By Brian Bossetta

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New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

More from North America

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

 
• By Brian Bossetta

The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By Elizabeth Orr

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

Dxcover Launches US Operations With New Headquarters In Tennessee

 
• By Natasha Barrow

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.