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The agency doesn't call out specific firms. Intuitive Surgical is studying its da Vinci Xi system in prophylactic nipple-sparing mastectomy procedures, but tells MedTech Dive it has the required approval.
The European Commission has advice on notified bodies, quality management systems and COVID-19 tests, among other topics, as medtechs work to comply with the new and looming regulations.
LumiraDx recently halved its full-year sales guidance after being buffeted by the same forces rocking larger COVID-19 test providers such as Abbott and Quidel.
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