News
Aug 26, 2016
Nancy Crotti The MonBaby baby monitor from MonDevice snaps onto a baby's clothing. Jørgen Behrens starts every day the same, reading reviews on Amazon and the...
Aug 24, 2016
Marie Thibault The AC5 Topical Hemostatic Device showed good safety and faster time to hemostasis in a 46-patient study. It's so far, so good for the AC5...
Aug 23, 2016
Marie Thibault ImPACT and ImPACT Pediatric have been FDA-cleared for use in assessing a person's cognitive function after a suspected concussion or brain...
Aug 18, 2016
Marie Thibault FDA has approved Edwards Lifesciences' Sapien 3 THV for use in intermediate-risk aortic stenosis patients. FDA has approved the Sapien 3...
Aug 11, 2016
Marie Thibault After much deliberation and years of waiting, FDA this week released two draft guidances on when a modification warrants a new 510(k)...
Aug 10, 2016
Marie Thibault The FDA approval covers MR-conditional labeling for Emblem S-ICD systems that have already been implanted. This week, FDA granted regulatory...
Aug 08, 2016
Marie Thibault Should clinical trial data be shared with any researcher who wants to study a medical question? Or does trial data belong to the original...
Aug 03, 2016
Marie Thibault Endologix's Nellix EndoVascular Aneurysm Sealing (EVAS) system, is a hotly anticipated device for which patients and clinicians may...
Aug 02, 2016
Marie Thibault ReliantHeart's aVAD intraventricular left ventricular assist device has received CE Mark. ReliantHeart’s new left ventricular assist device (...
Jul 28, 2016
Marie Thibault The days of mega deals in medtech will continue, according to one M&A expert, but the overall number of acquisitions of all sizes may dip—...