The Agency for Healthcare Research and Quality (AHRQ) posted a technology report on decision support tools for cardiac electrophysiology devices, but the effort yielded little evidentiary fruit to support the evaluation. The dearth of data suggests the impact of these tools on clinical decision-making could combine with cost pressures to suppress use of pacemakers and implantable cardioverter defibrillators in patients who are legitimate candidates. However, informed consent issues and questions of device de-activation are likewise conspicuous in the report, leaving researchers with a large set of poorly described variables to be explored in future studies.
There’s a saying that elections have consequences, an observation that has special meaning for the highly regulated medical device industry. Here are a few things for device makers to bear in mind as 2012 gives way to 2013. Supreme Court vacancies: Is PMA pre-emption back in play? The last time the U.S. Supreme Court reviewed FDA’s pre-emption of state regulatory mechanisms for PMA devices was Riegel v. Medtronic in 2008, and the decision came out in favor of the defendant. We previously discussed how the election might converge with retirements on the Supreme Court, but industry cannot assume pre-emption is...
