SafeHeal Set To Bring Colovac Colonic Bypass Sheath Into Clinical Trials
SafeHeal, a collaboration between an inventor-surgeon and Paris-based medtech accelerator MD Start, has enough funding to achieve a CE mark, and is looking for a partner to help it earn a 510(k) from US FDA.
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The number of medical device approvals reported outside the US rebounded in November after a very slow October. There were 14 CE marks, three approvals in Japan, and three in Canada last month, covering nine different product categories.
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.]