Getting Set For Sapien: With Data In, Discussion Moves To Adoption Dynamics

With all the major clinical data from Edwards Lifesciences' closely watched PARTNER trial now out in the open, there is little doubt among clinicians and industry analysts that transcatheter aortic heart valve replacements will be a U.S. commercial reality in the near term.

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Medtronic’s MiniMed Expands EU Uses Of MiniMed 780G And Readies For US Expansion Amid Competition

 
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Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.