Global Device Approvals, Weekly Snapshot: April 9-15, 2018
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
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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learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors.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.
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.
The company is sponsoring the first clinical study of robotically assisted electromagnetic-guided percutaneous access and mini-percutaneous nephrolithotomy – kidney stone removal – with the Monarch robotic-assisted platform for urology.