• Cepheid (Sunnyvale, California) said the FDA has categorized Cepheid's Xpert MRSA/SA Blood Culture (BC) test as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus in positive patient blood culture bottles. The test runs on Cepheid's GeneXpert system, the leading platform for on-demand detection of Healthcare Acquired Infections. The GeneXpert system is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert combines on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples.

• Cardiac Science (Bothell, Washington) reported the launch of the fourth generation of Burdick HeartStride exercise stress systems. This new version adds echo and nuclear systems connectivity to the existing connectivity with EMR/other systems. "With the connection to echocardiography and nuclear devices," said Ren Mitchell, Cardiac Science director of diagnostic marketing, "HeartStride allows the stress and imaging systems to use the same ECG signal. That's significant. Now the systems base their assessments off the same tracing."

• LifeNet Health (Virginia Beach, Virginia) said it has received FDA clearance for CardioGraft allograft cardiac patch products with MatrACELL decellularization technology. LifeNet Health received clearance for the technology for cardiac products, which safely removes donor cells from cardiovascular tissues while retaining the native biomechanical strength of the tissue.

• Sequenom (San Diego) reported the launch of an independent, prospective, multi-center observational study to document the performance of the company's SEQureDx Trisomy 21 technology for Down syndrome based upon Sequenom's SEQureDx technology. The study's primary goal is to document the performance (clinical sensitivity and false-positive rate) of Sequenom's T21 technology that uses fetal RNA in maternal plasma to identify Down syndrome in early pregnancy. The study has a secondary goal of developing a bank of samples to aid in improving SEQureDx T21 detectability in the identification of other chromosomal abnormalities.

• Siemens Hearing Instruments (Piscataway, New Jersey) has introduced its Motion line of hearing instruments. Motion includes the Siemens feedback reduction algorithm, advanced localization, automatic learning, and speech and noise management system, so even in complex listening environments there is no need to change programs or adjust volume settings. Plus, it is available with optional Tek Bluetooth wireless enhancement with Tek connect remote control that streams music, phone calls, and TV audio to the hearing instruments in full stereo sound. Motion is available with algorithms such as SoundLearning and DataLearning that remember sound quality and volume settings, and eWindScreen that continually analyzes incoming signals to detect wind noise, then automatically adjusts signal processing to reduce it.