FDAnews Device Daily Bulletin

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.

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

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

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.

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.

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.

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.

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.

If the legislation enforcing a 2.3 percent medical device tax, which is scheduled to take effect on Jan. 1, 2013, isn’t repealed, it could have a serious impact on U.S. jobs associated with orthopedic device companies.