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Fdanewsdevicedailybulletin

Dec. 21, 2011

Vol. 8 No. 248

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Clinical Trial Bias Questions Halt CardioMEMS at Circulatory Panel

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. Read More

Cranial Helmet Warning Response Earns FDA Closeout Letter

FDA investigators closed an inquiry into a Virginia devicemaker based on the company’s corrective actions, according to a June 8 closeout letter. Read More

China’s Department of Health Issues Device Alert for Cannulae

The Chinese Department of Health has issued a field safety notice for Medtronic International’s DLPR single stage venous cannulae. Read More

Scientists Find Safer Ways to Test Medical Procedures

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. Read More

FDA Approves Mechanical Cardiac Assist Device for Children With Heart Failure

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. Read More

FDA, Austen BioInnovation Institute to Collaborate on the Safety, Performance of Materials Used in Medical Devices

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. Read More

CardioMapper: First iPhone App to Use Bluetooth Smart

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. Read More

CADD-Solis VIP Ambulatory Infusion System Launches in Additional European Markets

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. Read More

Medical Device Tax Could Send 43K U.S. Jobs Overseas

If the legislation enforcing a 2.3 percent medical device tax, which is scheduled to take effect on Jan. 1, 2013, isn’t repealed, it could have a serious impact on U.S. jobs associated with orthopedic device companies. Read More