• Alliance Medical (Phoenix), a reprocessor of single-use medical devices (SUDs), reported FDA clearance of its Reprocessed Ultrasonic Scalpels 510(k). The instruments are used for soft tissue incisions when bleeding control and minimal thermal injury are desired. Reprocessed ultrasonic scalpels have the same intended use as the original device and do not incorporate new technology, materials or design changes, Alliance said.

• Cordis Endovascular (Warren, New Jersey) reported the U.S. launch of the Palmaz Blue Transhepatic Biliary Cobalt Chromium Stent, referring to it as “the latest advancement in balloon-expandable stent technology.” The Palmaz Blue stent features L605, a cobalt alloy enhanced with tungsten, and according to the company is stronger than stainless steel stents and uses less metal. It is designed to provide physicians with increased strength, radiopacity, low profiles and superior flexibility and deliverability. Cordis Endovascular said that each year, more than 30,000 Americans are affected by life-threatening blockages in the bile ducts. A biliary stent often is used to open the blockages so that fluids may continue to be transported to various organs such as the liver, gallbladder and small intestines. The Palmaz Blue Stent features a closed cell design, tapered radial arcs, optimized struts and double Omega hinges designed to optimize fatigue life, maximize radial strength and minimize foreshortening, the company said. The product is currently available in a .018 over-the-wire system in 4 mm to 7mm expansion diameter and 12 mm, 15 mm, 18 mm and 24 mm lengths. Cordis Endovascular is a division of Cordis, a Johnson & Johnson company.

• Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) reported ongoing pilot clinical trial progress of its BrainGate Neural Interface System in a poster presentation titled, “Case Study: Reliability of Multi-Electrode Array in the Knob Area of Human Motor Cortex Intended for a Neuromotor Prosthesis Application,” presented during last week’s International Conference on Rehabilitation Robotics (ICORR) hosted by the Rehabilitation Institute of Chicago. The BrainGate System is being developed to enable those with motor impairments resulting from a variety of causes to control a wide range of external devices. Interim results detailed in the ICORR poster presentation cover seven months of its ongoing pilot trial of the system in people with severe paralysis. In the study, researchers demonstrated the reliability of the BrainGate System to detect the activity of neurons over extended periods of time. They also reported on the use of newly developed software to automatically sort neuronal signals in about two minutes, a significant reduction over the 30-minute time span previously required for technicians to manually sort neuronal signals. This automated process appeared to extract data from more neurons than were previously extracted manually. The automated software element is a key building block for the company’s M*Power Controller System.

• Dermisonics (West Conshohocken, Pennsylvania), an ultrasound device manufacturer, said it has filed a provisional patent application for the U-Wand, a hand-held ultrasonic device for which the company has recently undertaken initial development work. The U-Wand is designed to deliver cosmetic formulations to the surface of the skin. The company devised the technology as a means of using its broader U-Strip technology – a drug delivery system incorporating a transdermal patch in combination with microelectronics and ultrasonic technology – for consumer applications.

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