First test to quickly diagnose MRSA and MSSA
MicroPhage Inc.'s (Longmont, CO) KeyPath MRSA/MSSA Blood Culture Test-BT has been approved by the FDA. It is the first test for Staphylococcus aureus infections that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA).
The test determines whether bacteria growing in a patient's positive blood culture sample are MRSA or MSSA within 5 hours after bacterial growth is first detected in the sample. Aside from blood culture equipment, the test does not require any specific instruments to obtain results.
Clinical tests show that the test was 98.9% accurate for MRSA determination and 99.4% accurate for MSSA determination.
Thermography no substitute for mammography
The FDA notified consumers and healthcare professionals that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. The agency is not aware of any valid scientific data to show that thermography devices used alone are an effective screening tool for any medical condition, including the early detection of breast cancer.
The agency is concerned that women will believe the misleading claims about thermography being promoted on websites and by mobile units claiming that thermography is a substitute for or superior to mammography. Some have also claimed that thermography can detect precancerous abnormalities and diagnose breast cancer long before mammography, and that compressing the breast during mammography will cause or spread cancer.
For more information visit http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedical.
Single-use ear sensor for pulse oximetry monitoring
Masimo (Irvine, CA) announced FDA approval and limited market release of the Masimo E1, the first single-patient-use ear sensor for pulse oximetry monitoring. Compared with digit sensors, the E1 enables faster detection of oxygen saturation changes during low perfusion due to a variety of clinical factors, including sedative or medication-induced vasoconstriction. It avoids cross-contamination risks for patients and reduces the complexity of sensor management for clinicians, including cleaning, storage, and transport.
The E1 is placed securely in the cavum conchae, and is made of durable soft silicone. It has no moving parts that can entangle in the hair or irritate the skin. It also avoids problems associated with forehead sensors and ear lobe sites for pulse oximetry.
FDA approves device to treat brain aneurysms
The Pipeline Embolization Device, a product of ev3 (Menlo Park, CA), has been approved by the FDA to treat brain aneurysms without needing to perform open surgery.
The device is a flexible mesh tube made of platinum and nickel-cobalt chromium alloy that can be used to block off a large, giant, or wide-necked aneurysm in the internal carotid artery. It can also reduce the likelihood that an aneurysm will rupture.
The device is implanted via a catheter that is inserted into an artery in the leg and threaded into the carotid artery and into position at the aneurysm, where the Pipeline is expanded against the walls of the artery and across the neck of the aneurysm to cut off blood flow to the aneurysm. The blood remaining in the blocked-off aneurysm forms a clot that reduces the likelihood the aneurysm will enlarge or rupture. Aneurysms treated with the Pipeline will often shrink over time, the FDA states.
Tracking of adverse events associated with the Pipeline showed that 10 strokes occurred in 9 patients in the year after treatment-significantly less than the 20% rate expected for this condition, according to the FDA.
For more information, visit http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm250083.htm.