January 22, 2016
Medtronic's Micra TPS
Medtronic's miniature leadless pacemaker, the Micra Transcatheter Pacing System (TPS), is expected to secure FDA approval during the company's 2017 fiscal year. That stretches from May 2016 through April 2017, so this potential approval may not take place until 2017. Still, with leadless pacemakers on numerous lists of top medical technologies to watch, we couldn't leave it off this list.
Micra TPS received CE Mark in April 2015. Medtronic announced positive results from its Global Clinical Trial in November 2015 and filed a PMA submission with FDA during the second quarter of fiscal year 2016 (August-October 2015). Management has not publicly discussed a narrower approval timeframe than fiscal year 2017.
These products do not have U.S. FDA regulatory clearance or approval as of January 22, 2016.
Continue on to "10 Hot Devices We Can't Get in the U.S."
[Image courtesy of MEDTRONIC PLC]
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