News
May 27, 2016
Marie Thibault Women's health devices have been in the spotlight in recent years for all the wrong reasons. Laparoscopic power morcellators fell out of favor...
May 25, 2016
Marie Thibault Senseonics, a relatively new entrant to the diabetes industry, has signed an exclusive distribution deal with Roche for its Eversense...
May 25, 2016
Marie Thibault In an example of the continued merging of medical devices and digital health technologies, weight loss device company Apollo Endosurgery and...
May 19, 2016
Marie Thibault The study included older transcatheter aortic valves from Edwards Lifesciences, not the latest Sapien 3, pictured here. As many as half of...
May 17, 2016
Marie Thibault FDA has published a draft guidance document explaining its perspective on diagnostics devices that use next-generation sequencing to identify...
May 16, 2016
Marie Thibault Legislators in the House of Representatives have banded together to introduce a bill that would delay Medicare reimbursement cuts, in order to...
May 10, 2016
Marie Thibault TransEnterix still anticipates submitting a 510(k) application for the ALF-X System this year. The SurgiBot System did not receive 510(k)...
May 05, 2016
Marie Thibault Putting to rest some speculation about what the initiative’s future will be, a CMS leader confirmed today that the Parallel Review program will...
May 05, 2016
Marie Thibault HeartWare's MVAD, shown here in a photo taken before the CE Mark trial was halted, is undergoing bench testing. MVAD, HeartWare’s next-...
May 03, 2016
Marie Thibault Medtronic's Visia AF MRI SureScan and Visia AF single-chamber ICDs received FDA approval. FDA has approved a two-for-one technology, the Visia...