MAHWAH, N.J., Sept. 20, 2011 /PRNewswire/ — MAQUET Cardiovascular, a leading provider of cardiovascular technologies, announced today that it has received both 510(k) clearance from the U.S. Food & Drug Administration (FDA) and CE mark approval from the British Standards Institution (BSi) for its new SENSATION PLUS™ 50cc 8 Fr. intra-aortic balloon catheter. The new SENSATION PLUS intra-aortic balloon (IAB) catheter is the first 50cc 8 Fr. IAB catheter to combine fiber optic signal acquisition with greater hemodynamic support compared to a standard 40cc IAB catheter.
The U.S. Food & Drug Administration slapped three medical device companies with Class 1 recall status for their heart devices.
Amid lawsuits concerning its Pinnacle metal-on-metal hip implant, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics won U.S. Food & Drug Administration clearance for its next-generation Pinnacle ceramic-on-metal hip implant.
Ceramic-on-metal is a novel combination in the hip implant market, having undergone two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing as part of the clearance process.
Mazor Robotics Ltd. (TASE:MZOR) unveiled its new Renaissance device, the next generation of its spinal robotic surgical guidance systems technology, which extend potential applications to more complex spine surgeries.
The new system is built on the core of the previous generation SpineAssist technology, which has been successfully used in more than 2,000 surgeries worldwide, accurately placing more than 12,000 implants, according to company officials.
Abbott Laboratories (NYSE:ABT) landed FDA approval for a new testosterone-boosting product.
The company’s AndroGel 1.62% is treatment for male low testosterone levels, also know as hypogonadism, which affects nearly 14 million men in the United States, according to the company.
The FDA recalled vascular devices made by Maquet Cardiovascular LLC and Millar Instruments Inc.
The federal watchdog agency classified the recalls as Class I, its most serious level of product clawback, indicating a reasonable probability that the use of the recalled product "will cause serious adverse health consequences or death."