• Eden Spine (Lake Mary, Florida) said that it has received CE-mark approval for its interspinous medical device, the Wellex. Biomechanically, the Wellex maintains flexion, axial rotation and lateral bending but, more importantly, is not an extension blocker. Rather, it controls extension dynamically, thereby positively affecting the neutral zone and reducing disc and facet loading. Multi-level implantations are possible.

• Life Spine (Hoffman Estates, Illinois) reported the launch of Apex, a system that can be used for anterior, antero-lateral and lateral fusion procedures. The instrumentation and flexibility of the Apex system can assist surgeons to match the surgical approach to the specific pathology of the patient.

• Lumen Biomedical (Plymouth, Minnesota) reported FDA clearance for the LBI Embolectomy system for use in the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. The LBI Embolectomy system consists of a 0.014" guide wire containing a 3-dimensional fiber-based element used in combination with the previously cleared Xtract aspiration catheter. The expandable element conforms to the vessel wall while pulling thrombus under aspiration toward the large, single-lumen design of the catheter. System bench testing demonstrated excellent thrombus removal compared to a balloon embolectomy catheter, with the potential for less vessel trauma. The models treat vessel diameters ranging from 3.5 mm to 7.0 mm.

• NeuroMetrix (Waltham, Massachusetts) said it has started shipping Needle Electromyography (EMG) modules for its Advance NCS/EMG system. The Advance EMG module interfaces seamlessly with the Advance device to provide high performance acquisition of needle electromyography signals with simultaneous graphical display and output through a 3" loudspeaker. The software provides physicians with straightforward control over data acquisition modes and a trigger for capturing of motor unit action potentials.

• Reliant Technologies (Mountain View, California) reported FDA clearance for three new Fraxel re:pair laser handpieces. These handpieces expand the capabilities of the Fraxel re:pair laser system, providing physicians with a complete skin resurfacing and surgical treatment option. As part of the Fraxel re:pair Complete Fractional Ablative Workstation, all three surgical handpieces can be used either alone or in combination with each other, without turning the system off to change handpieces. For skin resurfacing, the new Fraxel re:pair 600 micron handpiece performs superficial procedures both on and off-the face, including the neck, hands and chest, and treats fine lines, age spots and sun spots. The 600 micron handpiece can treat up to four times faster than any other ablative fractional device and provides a more uniform treatment with better results and faster healing for patients.

• Unitech (Taipei, Taiwan) said it has launched the PA600 Healthcare PDA. The PA600 Healthcare PDA is a compact and rugged mobile computer with an integrated 13.56MHz High Frequency RFID reader. The unit also supports 2-D barcode, making it ideal for any medical RFID applications, according to the company. The Unitech PA600 Healthcare PDA is especially targeted for healthcare application, with a case constructed from anti-microbial material, and is capable of housing both RFID and 2-D barcode readers. This feature enables hospital staff to correctly identify patients by reading their RFID-enabled wrist bands and ensure that the correct treatment is administered to the correct patient when scanning medicines.

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