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A negative devices advisory panel opinion, based on inconsistencies in clinical trials, may jeopardize a hoped-for buy-in by St. Jude Medical for the CardioMEMS monitoring device for heart failure.
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FDA investigators closed an inquiry into a Virginia devicemaker based on the company’s corrective actions, according to a June 8 closeout letter.
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Scientists are developing ever more sophisticated versions of “virtual patients” with the aim of testing medical devices and procedures that can’t readily be assessed in real people.
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The U.S. Food and Drug Administration approved a medical device that supports the weakened hearts of children with heart failure to help keep them alive until a donor for a heart transplant can be found.
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Austen BioInnovation Institute in Akron and the U.S. Food and Drug Administration have entered into a ground-breaking collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices.
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CardioMapper, the first app to use the Bluetooth Smart low-energy spec, is now available in Apple’s AppStore and available for iPhone 4S users.
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Smiths Medical announced it launched the CADD-Solis VIP ambulatory infusion system with CADD-Solis medication safety software in France, Germany, Switzerland and the Netherlands.
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If the legislation enforcing a 2.3 percent medical device tax, which is scheduled to take effect on Jan. 1, 2013, isn’t repealed, it could have a serious impact on U.S. jobs associated with orthopedic device companies.
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