A simple test is now available in the Wichita, Kansas, area that determines if the aspirin you are taking to prevent a heart attack or stroke is effective. The AspirinWorks (Denver) Test is available to doctors across Kansas through AMS Laboratory. The AspirinWorks Test determines the effect of aspirin on platelets by measuring the level of the biomarker called thromboxane B2 (11dhTxB2). The higher the levels of thromboxane B2, the stickier the blood platelets, and the less impact the aspirin is having. This crucial information allows physicians to individualize a patient's therapy, which may be as simple as adjusting the dose.

• BrainScope (Chesterfield, Missouri) reported the completion of data acquisition in high school athletes with mild traumatic brain injury (mTBI) as part of an ongoing investigational study of its brain assessment device. BrainScope's device focuses on the detection of traumatic brain injury. This new technology, which is in development, will operate as a digital translator of electrical brain activity, allowing medical professionals to quickly obtain adjunct clinical information based on a quantitative assessment of a patient's need for further diagnostic evaluation and appropriate treatment.

• CardiacAssist (Pittsburgh) said it has introduced a longer cannula set to cardiologists and cardiac surgeons to be used with its TandemHeart cardiac-assist device. The company says the TandemHeart system is the only percutaneous "extracorporeal circulatory support" device approved by the FDA for sale in the U.S. and is now being used in 100 of the elite cardiac centers across the U.S. All other heart assist devices are labeled by the FDA to be used for "partial circulatory support" because of their limited capacity to pump blood. On the other hand, the TandemHeart device is FDA-cleared for circulatory support for critically ill patients and can be placed rapidly in a cath lab or an operating room. In addition, the TandemHeart System is fully reimbursed by Medicare under existing DRG codes.

• Cepheid (Sunnyvale, California) reported details of technology expected to revolutionize the speed of diagnosis of Mycobacterium tuberculosis (TB) and the resistance to common drug treatment for the disease. The new test technology will leverage the power of Cepheid's GeneXpert System to deliver an accurate diagnosis of the disease in less than two hours. Xpert MTB/RIF not only detects the presence of TB, but also identifies whether it is resistant to Rifampicin, a common first-line drug for treatment of the disease and a reliable surrogate marker of strains that are multidrug-resistant. The test is expected to enable physicians to dramatically improve patient outcomes possible only with on-demand, actionable results to guide therapy decisions within the timeframe of an initial patient visit.

• Delcath Systems (New York) said that the data and safety monitoring board reviewed clinical data on the first 51 patients enrolled in the Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver. The Phase III study is testing Delcath's PHP system for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The Delcath system is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while preventing entry of the drugs to the rest of the patient's circulation. This isolation limits toxicities that result from systemic chemotherapy treatments.

• Edwards Lifesciences (Irvine, California) reported completion of enrollment in the 350-patient non-surgical study arm of its U.S. pivotal trial – known as the PARTNER Trial – for the Edwards Sapien transcatheter aortic heart valve. "Reaching this milestone is a significant achievement for the subset of patients suffering from severe aortic stenosis who can't tolerate conventional aortic valve replacement. Without a transcatheter heart valve, they have no definitive treatment options for addressing their valve disease," said Craig Smith, MD, a co-principal investigator for the trial.

• Imaging Diagnostic Systems (Fort Lauderdale, Florida) said that it has enhanced its CT Laser Mammography (CTLM) system with a reconstruction algorithm that improves visualization of angiogenesis (cancer) in its images. During a CTLM examination, the breast is illuminated by a laser and the transmitted light is collected by a series of photo detectors and transformed into digital data. The reconstruction algorithm uses this data to create the various images of the breasts. The improved algorithm enhances the images by reducing the number of artifacts occasionally produced during an examination thereby making diagnosis easier.

• Pathway Medical Technologies (Kirkland, Washington) reported FDA clearance for the Jetstream G2, specifically for use in breaking apart and removing thrombus (or blood clots) from the upper and lower extremity peripheral arteries. Jetstream G2, Pathway's newest peripheral atherectomy catheter, is capable of treating the entire spectrum of disease found in patients suffering from PAD, including hard and soft plaque, calcium, fibrotic lesions and thrombus, with consistent results. Jetstream G2 is a peripheral atherectomy catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. This solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD.

• Sparta Systems (Holmdel, New Jersey) has introduced WHAT IT TERMS "best-in-class" Web Services capabilities for its TrackWise Enterprise Quality Management Solution (EQMS). TrackWise's new Web Services functionality enables this market-leading EQMS to perform real-time interaction with enterprise software systems including Enterprise Resource Planning, Customer Relationship Management, Laboratory Information Management Systems and Manufacturing Execution Systems.

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