US Approvals Analysis: Biotronik Making Its Interventional Mark
The German-headquartered firm is making a play to enter the US vascular intervention market, with two stents approved by FDA under original PMAs in the first quarter of 2017. Cardiovascular devices, in general, have gained the most novel-device approvals so far this year, followed by IVDs. Check out more from a Q1 look at US FDA approvals and clearances monitored by Medtech Insight's Approvals Tracker.
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Global Approvals Analysis: LivaNova, Abbott, Medtronic, Boston Scientific Lead List Of January Cardio Approvals
January brought 23 non-US approvals, including 13 CE marks, according to Medtech Insight's Approvals Tracker. The total for January 2018 also exceeds the 20 non-US approvals recorded a year ago.
iCAD won US FDA approval for its PowerLook Tomo Detection computer-aided detection tool for the growing field of digital breast 3D tomosynthesis product. It's intended to address a key complaint by radiologists with tomosynthesis: the long time it takes to read 3D, compared to 2D exams.
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.