• ATS Medical (Minneapolis) reported the U.S. launch and first clinical uses of the ATS CryoMaze surgical ablation clamp. The clamp is similar in clinical use to other ablation clamps on the market; however, it is unique in that it uses argon-based cryoablation to create lesions rather than heat-based RF energy. The benefit of this ablation clamp is an ablation window that allows the surgeon to visually confirm complete freezing of the targeted tissue, providing confidence that the lesion has fully penetrated the tissue. The company's ablation treatments have been predominantly performed as part of concomitant open-heart procedures. ATS said it anticipates that the ATS CryoMaze Clamp will "greatly expand" its use in concomitant ablation during closed-heart procedures.

• CardioNet (Conshohocken, Pennsylvania) reported the release of its new atrial fibrillation (AF) reporting package to enhance its current AF Management Program. The program offers a tool to the physician for the diagnosis, treatment and management of their AF patients. The program additionally provides physicians with a monitoring program to evaluate the clinical efficacy of catheter and surgical ablation procedures allowing improved management of these post surgical patients.

• DNA Direct (San Francisco) said that the company will offer ColoSure, a test to screen for colon cancer. ColoSure tests a single stool sample for a DNA marker associated with colorectal cancer. ColoSure is the first clinical test available that looks for a DNA change in the vimentin gene, shown to be important to immunity and other important cell processes in the body. If the vimentin gene is hyper-methylated, or "turned off," this could indicate colon cancer, according to the company. A study published in the September issue of the American Journal of Gastroenterology shows that detecting methylated vimentin DNA in feces provided both high sensitivity (77%) and high specificity (83%) for detecting early-stage, curable colon cancers. DNA Direct's personalized, web-enabled report for recipients of the ColoSure test includes an overview of test results, a lab report and letter to bring to their physician, and recommended next steps. Reports also reinforce awareness of the signs and symptoms of colorectal cancer, and include an option to schedule a reminder for the patient's next screening.

• Medseek (Birmingham, Alabama) the leading provider of enterprise portal connectivity solutions, reported that four health systems have gone live with Medseek consumer portals to improve consumers' awareness of, and online experience with, the provider organizations. The consumer portals enhance consumer access to health information and services including the ability to research medical information, request appointments online, preregister for classes and inpatient services, pay bills, send patient e-greetings to friends and family members visiting the hospital, or find support groups.

• NeuroMetrix (Waltham, Massachusetts) said that it has received clearance for its Universal Electrodes. These electrodes are intended to be used with the NeuroMetrix Advance NCS/EMG system for performance of nerve conduction studies. The universal electrodes are individually placed electrodes which are not configured for specific nerves or limbs. They are disposable and for single-patient use.

• pSivida (Boston) said that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has again recommended that the two pivotal Phase III clinical trials, known collectively as the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) Study continue under the current protocol, without change. The trial is studying the use of Medidur FA for the treatment of diabetic macular edema (DME) being conducted by licensing partner Alimera Sciences. Medidur FA will be marketed under the name Iluvien. Medidur, a tiny, injectable insert, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema. Using a 25-gauge injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.