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Want Better Clinical Trial Design? Get Early Patient Input, Says FDA

 
• By Elizabeth Orr

A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.

Doctor working with diverse patients.
• Source: Prostock-studio / Alamy Stock Photo

Early feedback from patient advocates when designing a clinical trial could mean faster and more successful trials, the US Food and Drug Administration said in a 26 January guidance document.

The document, “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies,” is part of a push...

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Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

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Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
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• By Natasha Barrow

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Abbott Launches Next-Gen Delivery System For Proclaim DRG Neurostim

 
• By Shubham Singh

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Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

 
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In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.