New Glucometer Eliminates Coding
Abbott Diabetes Care (Alameda, Calif.) has launched the FreeStyle Lite blood glucose monitoring system for people with diabetes following its approval for marketing. The new system has an automatic calibration feature that eliminates the need for manual coding before starting a new vial of test strips. The small sample size and automatic calibration make it easier for patients to test their blood glucose level quickly.
The FreeStyle Lite provides rapid, accurate blood glucose results in an average of 5 seconds and offers virtually pain-free testing because of the very small blood sample size (0.3 microliter) required. The meter is small in size but has a large, high-contrast display and a backlight for easy testing and viewing. Like the other meters in the FreeStyle line, the FreeStyle Lite allows testing on alternate parts of the body such as the forearms, thighs, and palms.
Test for Methicillin-Resistant Staph Approved
The FDA has approved Cepheid's (Sunnyvale, Calif.) Xpert MRSA test for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA). The Xpert MRSA test delivers results in just over 1 hour. Rapid identification of MRSA carriers allows healthcare practitioners to implement proper infection-control measures, reducing hospital-acquired infection rates while improving patient care.
The Xpert MRSA test runs on the company's GeneXpert system, a closed, self-contained, fully integrated and automated platform that combines onboard sample preparation with real-time polymerase chain reaction amplification and detection functions. The system is designed to deliver answers directly from unprocessed samples.
Cepheid is working with a cross-section of healthcare organizations on MRSA surveillance programs to use the test in active MRSA surveillance programs nationwide.
Recall of CPAP Devices Announced
The FDA and ResMed have notified consumers and healthcare practitioners of a worldwide recall of approximately 300,000 S8 flow generators (Continuous Positive Air Pressure; CPAP) used for the treatment of obstructive sleep apnea. In Model S8 devices manufactured between July 2004 and May 15, 2006, there is a potential for a short circuit in the power supply connector.
ResMed will work with its distribution partners to provide a replacement device to patients who have a Model S8 affected by the recall.
Patients may continue to use their S8 devices until they receive a replacement device. Patients should make sure that it is placed on a hard, clean surface and that the area around the device is clear during use. Patients should discontinue using the device if there are any signs of electrical failure.
Patients should not use supplemental oxygen with an affected device.
For more information and a list of serial numbers included in the recall, visit http://www.fda.gov/medwatch/safety/2007/safety07.htm#ResMed.
Kit May Increase Conception Chances
The FDA has approved the Conceivex Conception Kit, the first at-home conception kit that can help women increase their chances of becoming pregnant without invasive procedures or expensive medications.
The kit includes fertility prediction tools, semen collectors, and the only FDA-approved cervical cap for conception, which are designed to be used together for up to 3 months to enhance a couple's opportunity to conceive. The conception cap brings the semen into direct contact with the cervix for 6 to 8 hours, increasing the opportunity for fertilization.
According to Conceivex, each element of the kit works together to address the more common issues that interfere with conception. The kit can be purchased with a prescription or can be made available from healthcare providers.