FDA uses previous trial data to design faster study of certain ablation devices

Lately, strengthening the clinical trial enterprise has been the one of the main goals of the FDA's device arm (CDRH). It appears to be making some progress, as judged by the faster than expected approval of the latest generation of TAVRs made by Medtronic ($MDT) and Edwards Lifesciences ($EW). In the latest sign of the FDA's increased emphasis on speed, the agency touted its use of previous clinical trial data to "help support a less burdensome clinical trial design for future premarket approval applications" of global endometrial ablation devices to treat heavy menstrual bleeding. The FDA says trials will require fewer subjects and may not include a control group. More

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