Test for detection of H. pylori launched
Exalenz Bioscience (Modi'in, Israel) is ready to launch its FDA-approved BreathID Breath Test System for point-of-care detection of Helicobacter pylori in the United States. The simple, 13C-urea breath test is capable of detecting the presence of H. pylori in around 10 minutes.
The BreathID system is a clinically proven, breath test platform capable of analyzing parts-per-million changes in carbon 13 and carbon 12 ratios in a patient's breath. The BreathID system provides continuous, automatic, and real-time patient monitoring and data analysis.
The company is offering two options. The first is the Hp FasTest-an in-office testing platform that uses a dedicated BreathID device located in the practitioner's office, allowing H. pylori testing to be done in the office, with results in 10 minutes. The company is also offering the Hp Bag Test send-in service in certain states, which uses a testing center for analysis and reports results within a few days.
For more information, visit http://www.exalenz.com.
Glucose monitoring system launched
Arkray, Inc. (Edina, Minn.) has launched the new Assure Platinum Blood Glucose Monitoring System, which was approved by the FDA in December 2009. The system is the first auto-code Assure brand blood glucose meter. According to Arkray, Assure glucometers are uniquely designed for long-term care and multiresident use settings. The Platinum is feature loaded and helps facilities meet state regulatory standards and provide better resident care.
Assure blood glucose meters are backed by the company's Assure Brilliance program to provide customer service, including on-site teaching, QA/QC guidance, continuing education programs online, and a quarterly newsletter.
For more information, visit http://www.assureusa.com.
Assist system approved for severe heart failure
The FDA approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation. The device was previously approved for use in patients awaiting further, perhaps more complex treatment, such as transplantation. HeartMate II is a product of Thoratec Corp. (Pleasanton, Calif.).
According to the FDA, the smaller size and mobility of the device should allow more patients, including women and men of smaller stature, access to treatment. While the HeartMate II does not replace the natural function of the heart, it does work along with the patient's own heart to pump blood.
In a clinical study of 200 participants, 46% of participants with the HeartMate II were still living after 2 years with no disabling stroke or need for a repeat procedure for device replacement or repair, compared with 11% of participants in the control group.
Reflux-testing tool approved
The FDA approved Crospon Ltd's (Galway, Ireland) EndoFLIP diagnostic tool for gastroesophageal reflux disease (GERD). The EndoFLIP enables precise measurement of the distensibility and functional diameter of the top portion of the stomach. According to the company, the EndoFLIP is the first tool to measure the mechanical properties of the lower esophageal sphincter, and is a key tool for understanding why a patient has GERD rather than the extent to which they have it.
The test takes 5 to 10 minutes and provides real-time dynamic imaging.
The EndoFLIP is useful as well for GERD surgery and in bariatric surgery to record data and assist surgeons in determining the degree of surgical tightening during surgery, which allows them to assess before and after results.
For more information, visit http://www.endoflip.com.