• Align Technology (Santa Clara, California) said that the FDA has cleared new labeling for the Invisalign system, thereby removing the permanent dentition limitation from the indications for use. In addition, certain conditions previously listed as contraindications will now be listed as precautions. In 1998, the FDA cleared the Invisalign system for use in patients with permanent teeth and contraindicated the device for patients presenting with mixed dentition, severe overbite, severe overjet, tooth malocclusion requiring surgical correction, adolescent patients with a skeletally narrow jaw, and adult patients with dental prosthetics/implants. The recently cleared labeling change was made based on a better understanding of the broader applications of the Invisalign system, advances in Align's manufacturing capabilities, and advances in the current practice of orthodontic treatment being administered by doctors using the Invisalign system.

• Amcom Software (Minneapolis) reported a significant update to its communications call center suite by introducing radio frequency identification (RFID) capabilities. With this update, Amcom claims to become the first provider of mission-critical call center software to offer precise, automated, staff location and management with RFID. The RFID technology works with the Amcom system to automatically update where hospital staff is located, so they can be contacted more quickly. Amcom's call center suite now uses Time Domain's PLUS line of precision ultra wideband (UWB) real-time location system (RTLS) tags, readers, antennas and software. With the design and implementation services of distribution partner, TrackIT Systems, facilities can quickly add the new RFID capabilities to their existing or new Amcom system. When personnel enter, leave or change locations within the facility, their contact records within the Amcom call center system are instantly updated. When a call center activity is initiated, precise information regarding their whereabouts makes it easy to use the individual's preferred messaging technology to reach them, wherever they are.

• BD Diagnostics (San Diego) said it has received FDA clearance to market the BD GeneOhm Cdiff molecular assay for the rapid detection of the Toxin B gene found in toxigenic Clostridium difficile, the bacterial pathogen responsible for C. difficile infection (CDI). The GeneOhm targets the Toxin B gene, found in virtually all toxigenic C. difficile strains, including the emerging BI/NAP1/027 epidemic strain. BD claims that it is the only CDI molecular assay that combines high sensitivity and specificity and provides definitive test results in less than two hours. This new test may facilitate earlier and more appropriate antibiotic treatment of CDI patients. It may also lead to earlier implementation of infection control interventions that help prevent the transmission of the pathogen to other patients. In the U.S., an estimated 500,000 people are infected annually, and more than 28,000 die from CDI.

• Clarient (Aliso Viejo, California) reported the commercial launch of its new gene expression test for prostate cancer. This new test will be available through Clarient's PATHSiTE virtual reporting tool and accessible to the company's entire pathology network. Clarient's new test is based on a combination of four genes that have been shown to accurately identify the presence of Grade 3 or higher (clinically significant cancer) prostate cancer cells in prostate tissue.

• Hiemstra Product Development (San Francisco) reported the introduction of hiQual, its electronic quality management system (eQMS). hiQual is Hiemstra's secure, web-based quality management system that is accessible to clients 24/7. The company says that the benefits of hiQual include increased productivity and improved communication by providing engineers immediate access to highly organized project documentation. A robust reporting engine monitors all business processes behind the scenes and provides statistical analysis for V&V. "With hiQual, Hiemstra now offers our clients a complete documentation package beginning with design and development through V&V and manufacturing," said Doug Hiemstra, president of the company."

• Illumina (San Diego) has launched the Infinium HD (high density) iSelect custom genotyping solution. With the release, Illumina says that researchers now have the flexibility to screen SNPs ranging from 3,000 to 200,000 in focused genotyping studies for both human and non-human species. This higher-density iSelect custom genotyping technology is the most versatile solution of its kind in the industry. It offers high data quality, high-throughput capabilities, and flexible sample multiplexing to screen any SNP in any species. The expansion of the Illumina iSelect offering provides researchers more freedom to design custom panels from the large amount of human variant information generated by research programs, such as the 1,000 Genomes Project. Agricultural researchers will be able to create more effective genotyping panels for complex or less well understood genomes.