New bariatric surgery imaging catheter approved
Crospon (Galway, Ireland and Carlsbad, Ca) has launched its EF-620 imaging catheter for bariatric surgery applications, the latest addition to the company's EndoFLIP range. It is designed to assist surgeons during gastric imbrication procedures.
According to the company, the EndoFLIP provides a unique capability to allow the surgeon to measure the inner diameter of the sleeve being created during surgery, which is considered essential for such sleeves to be created safely and consistently.
FDA approves wireless point of care testing system
Abbott's (Princeton, NJ) i-STAT 1 Wireless Point of Care Testing System handheld is now approved for marketing. The product is the company's new wireless version of the i-STAT Point of Care Testing System that is widely used in hospitals, EDs, and healthcare providers' offices. The new product allows real-time transmission of diagnostic test results generated by i-STAT 1 directly from the patient's bedside.
The i-STAT 1 Wireless system allows caregivers to share critical test information electronically without leaving the bedside, supporting a patient-focused approach to treatment and saving time and improving focus.
The new product is certified for compatibility with existing wireless networks and is also compatible with point-of-care data management systems used with earlier versions of the i-STAT system.
Test approved for detection of toxin B gene associated with CDI
Cepheid (Sunnyvale, CA) has received FDA clearance for its Cepheid Xpert C. difficile/Epi assay for the detection of the toxin B gene associated with Clostridium difficile infection (CDI). The automated test works on the Cepheid GeneXpert Dx System to detect toxin gene sequences associated with toxigenic C. difficile. In 45 minutes, the test determines if C. difficile is in a patient's stool and also if the strain is the epidemic 027/NAP1/BI strain that has been associated with a marked increase in severity and incidence of CDI in North America and Europe.
The test is intended for use as an aid in the diagnosis of CDI. The detection of the 027/NAP1/BI strain is for epidemiological purposes only and should not be used to determine or monitor treatment.
Advanced body composition assessment included in DXA system
Hologic, Inc. (Bedford, MA) has received FDA approval to incorporate the U.S. National Health and Nutrition Examination Survey (NHANES) Whole Body Reference Data into its Discovery dual X-ray absorptiometry (DXA) systems. Healthcare practitioners can use these body composition values to manage diseases and conditions when the disease or condition itself, or its treatment, can affect the relative amounts of fat and lean tissue.
The Hologic Advanced Body Composition assessment package provides a quick, accurate, precise low-dose X-ray exam to assess fat, lean tissue, and bone. A whole body composition scan can take as little as 3 minutes, is noninvasive, requires no injections, and is not painful. Color images displaying distribution of fat, lean tissue, and bone-with an easily interpreted report-aid in patient counseling.
HPV test approved for highest risk cervical cancer
Roche's (Basel, Switzerland) cobas Human Papillomavirus (HPV) Test is approved to identify women at the highest risk for developing cervical cancer. It is the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing.
The test individually identifies genotypes 16 and 18 while simultaneously detecting 12 other high-risk HPV genotypes. The approval was based on data from more than 47,000 women showing that 1 in 10 women age 30 and older who tested positive for HPV 16 and/or 18 by the cobas HPV Test actually had cervical precancer even though they had normal results with the Pap test.