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US FDA Approves First Intermediate-Risk Indication For TAVR

 
• By Reed Miller

The expanded indication for Edwards' Sapien XT and Sapien 3 arrives about when the company had predicted.

Edwards Lifesciences Corp. has beaten its rivals to yet another milestone in the development of transcatheter aortic valve replacement (TAVR) systems with the first US FDA-approved indication for intermediate-risk patients.

The agency announced Aug. 18 that it approved an expanded indication for Edwards' Sapien XT and Sapien 3 TAVR systems...

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Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 
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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.

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Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 
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European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
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As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.