During the most recent fiscal year, the FDA approved 98% of all high-risk devices submitted via its stringent PMA pathway, which requires large clinical trials. The rate is up from 86% in fiscal year 2014; the last time the approval rate was in the 90s was 2005. And the rate of approvals for lower-risk 510(k) devices rose to 85%. The numbers do not include the many subpar devices that are scuttled before they make it to the final submission stage. Still, they could help the FDA as it faces the potential passage of the 21st Century Cures act, which seeks to overhaul regulation of the U.S. device (and drug) sectors in a pro-industry manner. The approval rates are more proof that the FDA's device arm (CDRH) has become more industry-friendly under Dr. Jeffrey Shuren, who has said he seeks to approve devices as quickly as the European authorities. The agency still has a ways to go to catch up to Europe, but it's worth noting that the EU has been undertaking initiatives of its own that will likely slow down approval times across the Atlantic. Looking forward to 2016, the approval or rejection of Abbott's ($ABT) Absorb bioresorbable stent will be watershed moment. Although the device has consistently met its non-inferiority endpoint, its clinical data has raised some concerns in the cardiology community. Will the FDA feel compelled to approve the paradigm-shifting device because it earned a CE mark back in 2011? More (reg. req.)