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.
The 500-patient REPAIR MR trial will evaluate Abbott’s MitraClip mitral valve repair device in patients who would face moderate risk during open heart surgery. MitraClip is currently approved only for patients who are not surgical candidates.
Device Week, 17 January 2020 – FDA's Amy Abernethy Describes Medtech's Future; Researchers Want More Oversight Of Robotic Surgery
In this edition of Device Week, Medtech Insight's Marion Webb discusses her experiences at the recent Consumer Electronics Show in Las Vegas, including her interview with Amy Abernethy, who is the US Food and Drug Administration's principal deputy commissioner. Deputy editor Reed Miller discusses a recent study from the University of Michigan that suggests the growth of robotic-assisted surgery may be outpacing the evidence to support that technology.