GT Medical is touting results from a validation study showing its GammaTile therapy controls the regrowth of brain tumors with a low rate of adverse events.

CMS has completed its new national Medicare Coverage with Evidence Development policy for transcatheter aortic valve replacement. The final decision memo largely maintains the recommendations from the draft version released in March, including more flexible criteria for centers establishing TAVR programs, while emphasizing the importance of the interdisciplinary heart team for decision-making about valve replacement.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 18-24 June was very slow for approvals, with no new PMAs, panel-track PMA supplements, or de novos.

In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about her upcoming Market Intelligence story based on interviews with the biggest players in the diabetes market at the recent annual American Diabetes Association meeting. And Reed Miller discusses Global Kinetics' recent data on its Personal KinetiGraph that can help identify Parkinson's patients most likely to benefit from device-assisted therapy and Myriad Genetics' POLO trial results.

A new study shows the Personal KinetiGraph wearable monitor can help clinicians identify the Parkinson’s disease patients most likely to benefit from device-assisted therapies, including deep brain stimulation.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker, including a PMA supplement for Agilent’s PD-L1 IHC 22C3 pharmDx companion diagnostic for Merck’s Keytruda (pembrolizumab), an anti-PD-1 drug, for patients with head and neck squamous cell carcinoma. The US FDA also approved a supplement for the Cochlear Nucleus Profile Plus Series Cochlear Implant, designed to be safe with magnetic resonance imaging.