Novartis’ Alcon earned a CE mark for its automated, disposable, preloaded intraocular lens delivery system.
The nod from the FDA clears all blood collection establishments to follow its guidance and test for the virus.
PolarityTE announced the FDA registration of its skin-regeneration platform, which it will introduce in a limited release.
The FDA greenlighted Alere's rapid influenza diagnostic test, which detects infection in adults and children in as few as five minutes.
The FDA approved Medtronic’s HeartWare implantable heart failure pump as a destination therapy for heart failure.
Having cleared the last regulatory hurdles, Abbott will close its deal to acquire Alere on Tuesday.
The FDA OK'd Abbott’s FreeStyle Libre Flash glucose-monitoring system, which does not require fingerprick calibration.
The regulatory nod clears the cardiac disorder specialist to start selling the atrial fibrillation device in the European Union later this year.
The pilot program will offer precertified companies an abbreviated regulatory path to market, freeing them from lengthy cycle times.
The FDA approved MR-conditional labeling for the Ellipse implantable cardioverter defibrillator.