@FierceMedDev: Merit Medical discloses warning letter regarding Merit Laureate hydrophilic guidewire. Release | Follow @FierceMedDev
> Medtronic ($MDT) has reported positive one-year results from a study of the Complete SE vascular stent for the treatment of atherosclerosis in the superficial femoral artery. "The investigators found the device easy to use in treating SFA lesions of varying complexity, which is indicative of clinical practice," said principal investigator Dr. John Laird of UC Davis Medical Center. Medtronic release
> Invuity has debuted its illuminated Eigr Taylor retractor system designed to enhance visualization and tissue retraction during spinal surgery. Invuity release
> Consumers Union, the advocacy arm of Consumer Reports, is urging Congress to require more rigorous testing before medical implants go to market and establish a better monitoring system to ensure patient safety. Story
> Boston Scientific ($BSX) has reported the U.S. launch of the TruePath chronic total occlusions device. "CTOs are very challenging, requiring additional time, resources and patient exposure to imaging contrast and radiation," said J. A. Mustapha, director of endovascular intervention at Metro Health Hospital in Wyoming, MI. "The TruePath device is an exciting new technology that allows me to effectively penetrate these difficult blockages with greater speed and ease, allowing access to untreated lesions and helping to improve overall patient outcomes." Boston Scientific release
> Diasense, a non-invasive device that will use the only direct diagnostic technique available to reveal diabetics' exact condition, is set to enter the market. Screening with the device will help patients prevent the onset of diabetic complications. Report
> Wright Medical Group ($WMGI) has announced the 510(k) clearance and limited launch of the Prophecy Inbone pre-operative navigation alignment guides for total ankle replacement. Full U.S. commercial release is expected during the second half of the year. Wright release
And Finally... Walgreens and CVS have begun to sell a fertility test to help men determine if they are producing enough sperm to get a woman pregnant. The drugstores have already made SpermCheck Fertility available online. Story