• Cape Cod Clinical Research (Osterville, Massachusetts) reported the launch of TrialDOCS, an online clinical document management tool. The company says that the capabilities of TrialDOCS will assist pharmaceutical and biotech companies in managing their regulatory documentation electronically across multiple US and international sites. TrialDOCS will enable investigative sites, site monitors, and pharmaceutical companies to view and manage their regulatory files via a secure website.

• Concentric Medical (Mountain View, California) reported the U.S. release of two new lengths of the Outreach distal access catheter for use in neurovascular interventions. The catheter provides neurointerventionalists additional access and support options during minimally invasive procedures in the brain. The Outreach catheter is designed for navigating tortuous anatomy or in situations requiring additional microcatheter support.

• Edwards Lifesciences (Irvine, California) said it is launching the Carpentier-Edwards Physio II mitral valve repair ring. The new therapy represents the next generation of the Carpentier-Edwards Physio ring, which the company said is the market-leading heart valve repair device. Edwards says the Carpentier-Edwards Physio II ring is a novel mitral valve repair solution. It is the only annuloplasty ring offering "shape optimization," which matches the geometry of the ring to the characteristics of the patient's diseased mitral valve, and does not limit repair options based on etiology, or cause, of the mitral valve disease. Several new features, such as a unique sewing cuff, provide surgeons with a device that is also easier to implant.

• Lenetix (Mineola, New York) reported what it said is a significant step in the development of an improved first and second trimester non-invasive fetal chromosomal screening test to detect Down syndrome and other genetic fetal conditions. Lenetix said that preliminary study results indicate a potential breakthrough in testing quality and accuracy while preserving the safety of mother and fetus. The maternal serum test made by uses methylation-sensitive amplification (MSA) of fetal nucleic acid markers. In the preliminary studies, more than ten clinical plasma specimens of various ethnicities provided by clinical partners were tested with clinical partners using the MSA approach.

• Masimo (Irvine, California) reported that a new multi-center study of 39,821 newborns was published in the January issue of the British Medical Journal. When compared to a cohort group of 108,604 newborns in whom no pulse oximetry screening was used, the study found that the addition of Masimo SET pulse oximetry screening before discharge increased detection of congenital heart disease (CHD) by 28% (from 72% to 92%). The researchers concluded that Masimo pulse oximetry screening of "all well babies in maternity units is practically feasible with a minimum use of nursing time" and that it "significantly improves" detection of duct dependent CHD. Researchers also commented that "the low false positive rate, the fact that other important pathology is unearthed by the screening and the likely reduced need for preoperative neonatal intensive care suggest that such screening will be cost-effective."

• Medusa Medical Technologies (Halifax. Nova Scotia) said its electronic patient care reporting software, the Siren ePCR Suite, now has an interface with the Philips HeartStart MRx monitor/defibrillator. Siren ePCR Suite is a patient care reporting system. It helps paramedics to administer care while recording critical patient data that they transmit in real-time to receiving facilities. Siren ultimately improves data accuracy by downloading data from the HeartStart MRx directly into the tablet PC software, including ECG, vitals, treatments, and events. This system helps to support a decrease of discovery-to-treatment times by enabling the patient's care to be evaluated and treatment to be given en route to the hospital.

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