• Nuance Communications (Burlington, Massachusetts), a provider of speech and imaging solutions, reported a new release of its Dictaphone Enterprise Suite, a dictation and speech-based transcription processing solution for healthcare organizations. Comprising Dictaphone's Enterprise Express VoiceSystem, Enterprise Express TextSystem, EXSpeech, and Enterprise Workstation, the suite streamlines and automate the way that healthcare professionals capture and convert dictation into online clinical information and manage all stages of the workflow process. The new release of the Dictaphone Enterprise Suite delivers enhancements that increase automation rates, improve report quality and simplify how organizations manage their workflow process. The suite combines both front- and back-end speech solutions which capture data directly from caregivers or which are part of a transcription processing system.
• OrthoHelix Surgical Design (Akron, Ohio), an early-stage company developing implants and instruments for use in hand and foot reconstructive surgery, reported receiving FDA 510(k) clearance for the Calcaneal Trauma System, a set of titanium, implantable, bone fixation plates and screws. Its intended use is to stabilize and aid in the fixation of fractures of the calcaneus. The system includes four fixation plates and an assortment of locking and non-locking screws. The plates are offered in two different sizes; standard and large in both left and right versions. The plates are fully contoured to provide a better fit with the lateral surface of the calcaneus and allow for multi-planar fixation.
• Smith & Nephew said its Orthopaedic Trauma & Clinical Therapies (Memphis, Tennessee) division received FDA approval for its Exogen 4000+ Bone Healing System, a low-intensity pulsed ultrasound device externally applied 20 minutes a day over the site of a broken bone. According to the company, it is the only bone stimulator using ultrasound technology approved to treat fractures that that have failed to heal and approved to heal specific fresh fractures faster. The company said the Exogen 4000+ is clinically proven to speed up the healing of certain new fractures by 38% and effectively heal 86% of hard-to-heal bone fractures. The system will launch in domestic and international markets in the fall of 2006, and will replace the Exogen 2000+. The more compact Exogen 4000+ features a larger screen for easier visibility, a simple one-button operation, and a louder audio beep to signal operation.