• FLEXcon (Spencer, Massachusetts), a maker of adhesive coating and laminating, reported the launch of FLEXcon MedFLEX, a line of label substrates that meets all performance criteria required by the FDA's proposed unique device identifier (UDI) rule. The legislation will require Class II and III medical devices distributed in the U.S. to carry a unique numeric or alphanumeric code with an identifier specific to each device or model as well as an identifier with current production information. The FLEXcon MedFLEX line is UL-certified in accordance with UL/IEC 60601-1 3rd edition marketing durability rub tests. All products are available for immediate UL adoption. In addition to the usage of materials that comply with UL/IEC 60601-1 3rd edition marking durability rub tests, and potentially UL-recognized materials, the FDA UDI rule will also require specific information and barcodes on all product labels. Manufacturers will also need to maintain the data gathered for track and trace purposes. FLEXcon MedFLEX products not only meet these requirements, they utilize FLEXcon's high-performance acrylic adhesives and their best thermal transfer printable topcoats. Three of the products are UL-recognized with inks and ribbons and all products are immediately adoptable into converters' UL files.

• IntelligentMDx (Cambridge, Massachusetts) said the FDA has cleared its automated molecular diagnostic test that detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). This is one of the tests in IMDx's portfolio of infectious disease products to be cleared by the FDA for use on Abbott's fully automated m2000 platform. VRE are bacteria which have become resistant to the antibiotic vancomycin, and are responsible for a variety of healthcare-associated infections, including surgical wound, urinary tract, and bloodstream infections. The IMDx VanR for Abbott m2000 assay is intended to be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The automated nature of the IMDx VanR for Abbott m2000 test allows laboratories to obtain results for up to 46 patient samples in less than 3 hours, and up to 94 patient samples in less than 4 hours. The assay is performed directly on human peri-rectal swabs, rectal swabs, or stool specimens from patients at risk for VRE colonization.

• Mirus Bio (Madison, Wisconsin) says it has expanded its transfection expertise with the development of the TransIT-X2 Dynamic Delivery System, a polymeric system for high efficiency nucleic acid delivery. TransIT-X2 can be used for independent or simultaneous delivery of DNA and siRNA. The company claims that in head-to-head testing, TransIT-X2 outperformed the market leader by at least 2-fold in cell types that include: A549, CHO-K1, Hep G2, HCC1143, HUVEC, LNCaP, MDA-MB-468, MDCK, HMEC, Immortalized Keratinocytes and T47D. Every transfection product offered by Mirus Bio is the result of scientific discovery and development from an in-house team of organic chemists, molecular biologists, cell biologists and biochemists. Almost two decades after its founding, transfection continues to be the focal point and passion of Mirus, giving researchers the most reliable products and expertise.

• SurModics IVD (Eden Prairie, Minnesota), a maker of in vitro diagnostic assay components, is launching its new StabilZyme Protein-Free Stabilizer at the American Association for Clinical Chemistry (AACC) meeting in Houston. SurModics IVD offers a range of solutions, including custom formulations, for the in vitro diagnostics industry, the company said. SurModics says its mission is to exceed our customers' expectations and enhance the wellbeing of patients by providing the world's foremost, innovative surface modification technologies and in vitro diagnostic chemical components.

• Teleflex (Limerick, Pennsylvania), a provider of devices for critical care and surgery, said its subsidiary Hotspur Technologies, which Teleflex acquired in June 2012, received FDA clearance to market the company's Arrow GPSCath Balloon Dilatation Catheters in Higher Rated Burst Pressure (RBP) and 80 cm lengths. These novel products enable multiple vascular procedures to be performed with one dual-function catheter, potentially reducing procedure time and expense for both patients and medical professionals. The Arrow GPSCath Catheter is a dual-functional balloon dilatation catheter that combines angioplasty and the proprietary VisioValve Injection System. This innovative combination enables physicians to perform high-pressure angioplasty and inject physician-specified fluids, such as contrast, all while maintaining the guidewire position.

• Thermo Fisher Scientific (Waltham, Massachusetts) showcased its offering of specialty diagnostics products and analytical instruments designed to improve accuracy and productivity in clinical applications at the American Association for Clinical Chemistry conference in Houston. Thermo Fisher reported that its new Thermo Scientific QMS Tacrolimus immunoassay has received FDA clearance. The liquid, ready-to-use immunoassay measures levels of tacrolimus on automated clinical chemistry analyzers, including the bench-top Thermo Scientific Indiko analyzer, to improve the quality of life for kidney, liver, and heart transplant patients. The company also marked the debut of another FDA-cleared product, the Thermo Scientific MAS Omni•CARDIO controls, an assayed control serum comprising a combination of cardiac and associated critical markers for use in clinical laboratories to monitor assay conditions. The single test eliminates the need for separate quality control measures between tests and provides rapid results.

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