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Medtronic’s CoreValve Makes Strides In Japan And U.S.

The Japanese regulatory authority has approved Medtronic’s CoreValve transcatheter aortic valve based on data from the CoreValve Japan trial and U.S. trial data. Meanwhile, FDA granted CoreValve its first TAVR approval for a "valve-in-valve" indication for patients with prior replacements.

Medtronic PLC’s CoreValve self-expandingtranscatheter aortic valve made regulatory headway in both Japan and the U.S. March 30.

CoreValve is closer to being able to compete with Edwards Lifesciences Corp.’s Sapien XT TAVR system for the first time in the large Japanese market after gaining regulatory approval...

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• By Ashley Yeo

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FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.