OUS Approvals Analysis: Slow Finish To 2016, But Still Ahead Of 2015
Executive Summary
2016 finished with just two more non-US medical device approvals than 2015; December was by far the slowest month of the year for approvals from outside the US with just 11.
You may also be interested in...
Medtronic Misses Mid-Year Mark With 'Disappointing' 3% Growth
The medtech giant says slow sales in its cardiovascular and diabetes businesses while it awaits important product approvals were a drag on its overall revenues during the second fiscal quarter of 2017.
HiberGene's Under-An-Hour Meningitis Test Hits Europe
Emerging Irish IVD company HiberGene Diagnostics has just CE marked HG Meningococcus, a molecular diagnostic test for bacterial meningitis that can detect Neisseria meningitidis in cerebrospinal fluid, whole blood and via a nasopharyngeal swab in less than one hour. The company is set to launch the test in Europe with distribution agreements in place for Ireland, Germany, Austria, Spain, Turkey and Poland.
Minute Insight: Abbott Rolls Out Navitor Next-Gen TAVR System To Catch Up To Medtronic And Edwards
Navitor is an upgraded version of Abbott’s Portico TAVR system with a better fabric cuff and large curved aortic “cells” to reduce the risk of injury to the native valve.