Karl Storz (Culver City, California) has launched its Telecam DX II camera control unit (CCU) to address the market for office-based video endoscopy systems. The company said the Telecam DX II CCU enables physicians to provide high-quality patient care while maintaining cost efficiency. It said the new system is well-suited to ob/gyn, urology and ear, nose and throat practices. The DX II has been designed to enhance image quality, adaptability and the degree of control the physician has over the system. It relies on fiberscope filters to remove more patterns and pixelation from images generated by flexible telescope scopes. Precise auto-exposure and brightness control are used to maximize the quality of every image. Interchangeable adapters for the Telecam DX II are available in 12 mm, 25 mm, 30 mm and 38 mm focal lengths. Programmable buttons enable control over as many as four camera functions directly from the camera head. The system's freeze-frame capability allows the physician to freeze images for discussion with patients or colleagues or for diagnostic interpretation.

Medical Services International (MSI; Edmonton, Alberta) reported that it has developed a rapid test kit for malaria and that it has finished all preliminary testing of the VScan Malaria test kit. Test results show that the kit is accurate (greater than 99% of the time), easy to use and gives results in under 20 minutes. The company said it has begun submitting the malaria test kit to regulatory authorities for approval in two countries and will be submitting it for approval in another nine countries within the next 60 days. MSI said that, based on the test results of the Vscan Malaria kit and the excellent test results of its other test kits, it expects to receive regulatory approval reasonably quickly. The company said that early diagnosis of malaria means that the disease can be treated before it becomes severe and poses a risk to a patient's life.

Reality Engineering (Vancouver, Washington) is introducing at the Chicago Dental Society midwinter meeting MedVisor/dental, a patient education and communication tool that translates highly technical details and procedures into easy-to-understand 3-D dental animations. MedVisor/dental debuts this week. "MedVisor beautifully translates complicated medical terms and procedures into understandable language through 3-D animations displayed on our computer screen," said Mark DiRe, DDS, of Bellevue, Washington. "I can depend on MedVisor to easily illustrate complicated diagnoses and operations to patients where before, reams of paper and hours of explanation would have been required and still may have fallen short." Custom import/export capabilities incorporate data unique to that individual.

Siemens Medical Solutions (Malvern, Pennsylvania) has received FDA 510(k) clearance for MammoReport(Plus), a mammography softcopy reporting workstation that Siemens is showcasing at this week's National Consortium of Breast Centers conference in Las Vegas. The clearance allows for the processing of digital computer-aided (CAD) images and mammograms from approved vendors, expanded indications for multimodality viewing, and use with FDA-cleared monitors for the interpretation of lossless compressed images. In addition, MammoReport(Plus) is now Windows-based, which enables it to run on syngo, the intuitive software platform from Siemens that delivers powerful networking and post-processing capabilities. MammoReport(Plus) works in conjunction with Siemens' Mammomat Novation(DR) to provide a comprehensive system solution for clinical processes in mammography.

SmartPill Diagnostics (Buffalo, New York), developer of the SmartPill Capsule, a non-invasive, ingestible medical device that captures biomedical data from within the patient's GI tract, reported that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are now underway at Massachusetts General Hospital (Boston). A total of 130 subjects and five clinical trial sites are expected to participate in 510(k) clinical trials of the SmartPill ACT-I Capsule and SmartPill GI Monitoring System. Of the 130 subjects, 70 are control and 60 are gastroparetic. Gastroparesis is one of the primary GI motility disorders in which the SmartPill ACT-I Capsule will aid diagnosis and management. Temple University Hospital (Philadelphia) will begin clinical trials next week, and three other sites will begin clinical trials shortly thereafter. The 510(k) clinical trials will be completed in May and will lead to 510(k) submission in June.

Zila (Phoenix), maker of an oral screening device, ViziLite, reported that in a newsletter issued by what it termed "an independent industry-influencer," dentist evaluators expressed confidence in ViziLite as a "non-invasive, easy-to-use" screening device for oral abnormalities. The company said the published review also acknowledged that "investigating suspicious lesions is potentially life-saving," lending further credibility to ViziLite as a screening technology for identifying oral lesions that could lead to more serious pathology if left untreated. Zila has introduced ViziLite to several dental teaching institutions, where training in the application of this technology has been integrated into the curriculum. Zila said that later this year, it will launch its new lesion marking device containing Zila Tolonium Chloride (ZTC), which will be marketed as an adjunct to ViziLite. The technology will enable dental professionals to mark suspicious lesions for further examination after they have been identified during a ViziLite exam. The marking device containing ZTC received clearance by the FDA earlier this month, and represents the first product containing ZTC to be marketed in the U.S.