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The FDA did not believe the company provided enough clinical evidence to support the expanded indication, as the system had not met the primary endpoints of its sebaceous hyperplasia study. Read More
The EU and its member states must take urgent action to increase the number of notified bodies authorized to certify devices under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) that goes into effect May 26. Read More
Revibe Technologies’ said its medical device software product, FokusRx, for the treatment of children with attention deficit hyperactivity disorder (ADHD) improved participants’ symptoms in a feasibility study. Read More
The litigation included patent infringement claims in the U.S. District Courts for the District of Delaware and the Eastern District of Texas. Read More
CooperCompanies is expanding its women’s health and fertility device portfolio in a $875 million purchase of Cook Medical’s reproductive health business. Read More
The FDA would be able to use outside evaluators to speed authorizations of in vitro diagnostic tests needed to identify the pathogens causing future pandemics if a bill pending in the Senate is enacted into law. Read More