• Medtronic (Minneapolis) reported that the FDA has granted pre-market approval to its new Specif 5-6-5 surgical lead for neurostimulation therapy, a treatment for chronic pain that uses the company's extensive line of implantable neurostimulation systems, including the RestoreADVANCED and PrimeADVANCED neurostimulators. Designed to improve the effect of neurostimulation therapy on low back pain, the Specify 5-6-5 surgical lead features 16 electrodes arrayed in three columns on a durable, flexible, curved paddle that conforms to the anatomy of the epidural space. The electrodes – six in the middle column and five in each of the outside columns – are embedded in the paddle with patent-pending DuraLoc electrode technology. They are arranged in a diamond pattern intended to maximize therapeutic effectiveness while minimizing energy consumption. Each electrode can be activated and programmed independently, which enables customization and adjustment of neurostimulation therapy based on individual patient needs.
• Phase Forward (Atlanta), a provider of data management solutions for clinical trials and drug safety, reported a new Submission Checking Service offering based on its Web Submission Data Manager. The service enables organizations to confirm to data from trials conform to the SDTM standard, so they can decrease the likelihood of delays caused by FDA data-related queries and submissions that are returned because of data discrepancies or inconsistencies.
• Smith & Nephew 's (S&N; Andover, Massachusetts) Endoscopy Division announced the launch of the 560 Series 3-CCD High Definition (HD) Camera System. It is a surgical camera system capable of capturing and displaying broadcast quality HD images in arthroscopic and other minimally invasive surgeries. Smith & Nephew specializes in orthopedic reconstruction, orthopedic trauma and clinical therapies, endoscopy and advanced wound management products.
• Thermage (California) reported that the FDA has provided a first-time-ever 510(k) clearance for the treatment of periorbital wrinkles and rhytids, including upper and lower eyelids. Thermage's technology provides a non-invasive procedure designed to tighten and contour skin, expanding the aesthetic applications physicians can offer to the rapidly growing anti-aging market.
• Veeco Instruments (Woodbury, New York) reported the release of its Innova scanning probe microscope (SPM) for a wide range of physical, materials and life science applications. The Innova SPMlab-V 7.0 software incorporates real-time signal diagnostics and processing options and offers access to scan and feedback parameters. Vecco Instruments makes atomic force microscopes for research applications.