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Rulemaking Can Only Do So Much: Stakeholders Weigh In On LDT Rule

 
• By Hannah Daniel

Investors and business executives weighed in on the FDA’s proposed rule on LDTs during a panel at the Medtech Conference on 9 October. 

• Source: Citeline

The new proposed rule for the US Food and Drug Administration’s oversight of laboratory developed tests (LDTs) can’t solve everything, Becton Dickinson’s Ami Simunovich said during AdvaMed’s Medtech Conference on 9 October.

Simunovich serves as the chief quality and regulatory officer and public affairs at BD. Based on her regulatory experience, she...

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Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
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The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

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Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
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