• NMT Medical (Boston) said it has received FDA approval for commercial sale of the company's StarFlex cardiac septal repair implant in the U.S. for patients with ventricular septal defects (VSD). The StarFlex implant can be placed in the heart to close the VSD using a catheter during a minimally invasive procedure, avoiding the need for the alternative treatment of open-heart surgery, which is considered a high-risk, invasive procedure. VSD is an opening between the right and left ventricle in the lower chambers of the heart and is the most common type of congenital heart defect. When there is a large opening between these ventricles, a large amount of oxygen-rich (red) blood from the heart's left side is forced through the defect into the right side. It is then pumped back to the lungs, even though it has already been filtered and refreshed with oxygen. This is inefficient, because oxygenated blood displaces blood that needs oxygen, which means the heart must pump more blood and may enlarge from the added work.

• SymCare Personalized Health Solutions (West Chester, Pennsylvania) said the FDA has cleared the inTouch diabetes program to support effective diabetes management. The new web-based system uses a combination of objective biometric data, education and a rewards program to better engage patients in effective diabetes management. The system offers patients a network of support and customized education and information while providing healthcare professionals with objective biometric data for more specific and personalized patient/healthcare professional interaction.

• ThermoGear (Portland, Oregon) reported introduction of the Chillbuster Portable Patient Warming System. The patient warming system has been in use by the U.S. Military for several years. The Chillbuster warming system includes single-use disposable blanket covers to avoid patient cross contamination. The technology is designed as a rugged system for use in the field and in all types of healthcare facilities.

• TomoTherapy (Madison, Wisconsin) cited recently published encouraging preliminary results of an ongoing Phase I clinical trial on the use of intensity-modulated (IMRT) and image-guided radiation therapy (IGRT) focusing on the concept of accelerated hypofractionation to overcome tumor repopulation, one of the well-known mechanisms of radiation resistance, using TomoTherapy for non-small cell lung cancer (NSCLC). The paper evaluates a study devised to test the safety of escalating the biologically-effective tumor dose via hypofractionated treatment regimens using 25 fractions over five weeks. According to its authors, the study demonstrates that the use of TomoTherapy technology may allow for higher doses of radiation therapy than are conventionally administered to be delivered over a shorter treatment course, with lower than expected toxicities. Helical TomoTherapy allows for delivery of image-guided, intensity-modulated radiation therapy, permitting conformal delivery of radiotherapy while minimizing the dose delivered to normal tissues.

• Torax Medical (St. Paul, Minnesota) said it has commenced a pivotal clinical trial of its Linx Reflux Management System. The trial will evaluate the safety and effectiveness of the Linx System in patients suffering from GERD despite medical therapy. The Linx Reflux Management System is intended to restore the normal barrier function in the esophagus for patients who suffer from GERD and is designed to be an outpatient, minimally invasive procedure. The device is implanted laparoscopically, with the patient likely to resume normal activities and diet at discharge. In addition to its therapeutic benefits, Torax Medical said it anticipates that the Linx System will have the potential to eliminate the burdens associated with lifelong drug therapy and the typical complications associated with conventional surgical repair.

• Vasomedical (Westbury, New York) said it has received FDA clearance to market Vasomedical-BIOX 1305 ECG Holter Monitor and CB Series Ambulatory ECG Analysis Software. The Vasomedical-BIOX 1305 Holter Monitor is the latest addition to Vasomedical's product line. The Model 1305, which has already received CE-mark certification to market in the EU countries, is a compact, lightweight, 3-channel ECG Holter monitor designed for monitoring a patient's cardiac rhythm for 24 to 72 hours and recording ECG on a standard SD memory card. It features a high signal sampling rate and high resolution digital recording for comprehensive data analysis. The data recorded on the 1305 monitor is utilized in the early detection of cardiac abnormalities such as ischemia and arrhythmia.

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