Global Device Approvals, Weekly Snapshot: April 9-15, 2018
Executive Summary
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
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Rise Of The Machines: FDA Artificial Intelligence Guidance Is Coming
US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.
AngelMed Cardiac Monitor Panned At FDA Panel Over Clinical Trial Concerns
An FDA advisory panel recommended against approval of the AngelMed Guardian System, an implant that watches electrical heart signals and sounds an alarm for early detection of ischemic events. The panelists couldn’t get past trial flaws, including failure to meet the primary endpoint and early cessation of patient enrollment.
Cardio Catch-Up: Medtronic, Recor, Pulnovo Report Progress On Denervation To Treat Hypertension
The late-breaking clinical trial presentations at this year’s Transcatheter Cardiovascular Therapeutics conference in Boston included new results from trials of three different minimally invasive approaches to treat uncontrolled hypertension.