The agency acknowledged MCIT "could be problematic" in ensuring devices demonstrate value without additional risks for Medicare beneficiaries, depriving industry for now of a long-sought policy goal.
Jeff Shuren said Wednesday the agency might miss some Medical Device User Fee Amendments performance goals for PMA applications and 510(k) submissions.
A total of 56 patients were examined 30 days after a transcatheter tricuspid valve replacement procedure. Edwards now plans to start a pivotal trial, examining the procedure in 775 patients.
The fast-growing product performed well in an analysis of more than 36,000 people presented at the American College of Cardiology meeting, with low adverse event rates that surprised even the study's author.
Prior to the COVID-19 public health crisis, momentum to transition operating rooms into digitally connected learning environments was building. Social distancing mandates accelerated those efforts.
The pump has a higher rate of malfunction reports than rivals, according to an ECRI analysis of the FDA's MAUDE database. But it's hard to draw conclusions from a disparate system of safety reporting.
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