• Cepheid (Sunnyvale, California), a molecular diagnostics company, reported receiving clearance to market its Xpert EV test, which runs on the GeneXpert System, for the presumptive qualitative detection of enterovirus RNA in cerebrospinal fluid (CSF) as an aid in the laboratory diagnosis of enterovirus infection in patients with a clinical suspicion of meningitis. The Xpert EV test, designed to detect enterovirus (EV) RNA in CSF by reverse-transcription real-time polymerase chain reaction (RT-PCR), is the first test of its type to receive FDA clearance, according to the company.

• Guardian Technologies International (Herndon, Virginia), a developer of intelligent imaging informatics solutions, said it completed the first round of clinical evaluations and a series of pilot studies involving multi-modalities and multiple diseases. Based on what it called "promising" R&D results, Guardian launched a broader survey designed to evaluate and validate the applicability of Signature Mapping to the medical imaging applications. A series of broad pilot studies involving multiple modalities and multiple diseases were undertaken through a collaborative effort with the Image Processing and Informatics Laboratory (IPI) at the University of Southern California. IPI provided clinical cases including radiographs with confirmed diagnoses, as well as medical imaging informatics expertise. The study areas included multiple sclerosis, acute intracranial hemorrhage, tuberculosis and breast imaging. The company said it was able to demonstrate its ability to easily transfer its Signature Mapping technologies to a new imaging industry application. The Signature Mapping technologies proved to be an effective tool for detection, segmentation, clarification, quantification and visualization for specifically targeted diseases or anatomical structures. The technology shows broad modality and clinical adaptation for deployment in a wide variety of clinical diagnostic and therapeutic applications, according to Guardian.

• Saint John's Health Center (Santa Monica, California) reported that a cardiologist used an investigational, endoscopically guided laser catheter to treat "short-circuiting" heart tissue that was causing a potentially dangerous arrhythmia in a 58-year-old man. The investigational device used in this procedure is called Visually Guided Endocopic Ablation System and was developed by CardioFocus (Marlborough, Massachusetts). The patient was the first to be treated in the ENABLE trial, a multi-center investigation at 20 hospitals. Director of cardiac electrophysiology, Shephal Doshi, MD, performed the investigational procedure, called Endoscopic Catheter Ablation. The patient suffered periodic episodes of irregular heartbeat, dizziness and fatigue for more than a year and was diagnosed with atrial fibrillation. Doshi and colleagues inserted a slender catheter into a vein in the patient's right leg up into his chest and guided into a large vein in his heart, using the investigational endoscopic video camera, small amounts of traditional real time X-ray and ultrasound imaging. Doshi inflated the balloon and was able to visualize the target tissue for the first time. Once the target was located, he turned on the laser, which released precisely controlled arcs of light around the vein. Several bursts of laser energy were able to destroy an area of abnormal tissue while causing no significant damage to surrounding healthy heart muscle.