December 2019 Approvals Snapshot: Abbott Earns New Approval For CentriMag Circulatory Support System
December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.
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Since receiving approval for the first broad-panel diagnostic test as a combination product to detect cancer, Foundation Medicine has ramped up its partnerships with pharmaceutical companies and other stakeholders. The company expects to receive a similar approval for a broad-panel liquid biopsy genomic test in the first half of 2020.
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.