Global Device Approvals Snapshot: 2-8 July 2019
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 2 July to 8 July was another slow one for approvals, with no new PMAs, panel-track PMA supplements, de novos, or non-US approvals.
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Digital Surgery, a London-based developer of surgical artificial intelligence, analytics, digital education and training solutions, will join Medtronic’s surgical robotics business within its minimally invasive therapies group.
In this edition of Device Week, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about his recent story on Abiomed's plan to counter unfavorable studies of its Impella heart pump.
[Editor's note: This article was updated on 14 February 2020 to clarify that Abiomed has invested more than $100m over the past five years in clinical research on the Impella heart pump platform. Abiomed has not committed to spend another $100m on new physician education and communication programs.]
Abiomed is trying to counter the negative publicity created by the recent publication of retrospective studies showing higher costs and worse outcomes in coronary intervention cases with Impella than in comparable procedures with intra-aortic balloon pumps. The company insists this analysis is deeply flawed.