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CDS Final Guidance Draws More Criticism, This Time From Congress

 
• By Hannah Daniel

Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.

• Source: Shutterstock

Senator Bill Cassidy’s (R-LA) letter to the US Food and Drug administration calls into question the agency’s statutory authority to regulate clinical decision support (CDS) software as a medical device.

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• By Amanda Maxwell

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Abbott, J&J Reaffirm 2025 Profit Guidance Despite Growing Tariff Uncertainties

 
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Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
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Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

More from Policy & Regulation

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 
• By Brian Bossetta

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Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
• By Elizabeth Orr

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Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
• By Marion Webb

Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.