HeartWare Updates Status Of Battles On Several Fronts
This article was originally published in Clinica
HeartWare is counting on its established HVAD technology to carry it through a difficult period as it struggles to relaunch the clinical trial of the MVAD miniaturized ventricular assist device.
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Device-giant Medtronic has agreed to pay $54.5m to settle a class-action suit filed by investors in HeartWare, which Medtronic bought in 2016. The plaintiffs say HeartWare misled investors about the safety of a miniaturized heart pump under development.
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.
The authors of a large cohort study of the uptake of robotic-assisted surgery in Michigan hospitals argue that the rapid adoption of robotic techniques is not supported by existing clinical evidence.