A recall of 34 units of Draeger's Perseus A500, an anesthesia workstation, has been categorized by the FDA as Class I. The recall was issued over concerns about a faulty power switch that may cause the device to shut down and alarm unexpectedly.
Draeger has allowed Canadian and U.S. anesthetists at London's University Hospital to test its anesthesia ventilators in an effort to market its device in North America. The device, which already is approved in Europe, works by allowing anesthetists to control the amount of painkillers that should be given to patients while the device administers and monitors the dose.
Medtronic Sofamor Danek has filed a lawsuit alleging that NuVasive's spinal devices infringe on 12 patents across four product lines. NuVasive obtained a copy of the complaint and is evaluating its legal options, CEO Alex Lukianov said.
U.S. researchers reported that they have developed a four-step process to generate red blood cells from human embryonic stem cells, raising hopes for the large-scale production of blood-transfusion supplies in the laboratory. A blood expert, however, said further studies must be done to determine whether the technique can create red cells capable of surviving long enough in the human body to be useful.
The British National Institute for Health and Clinical Excellence is set to release a final guidance recommending that children of people with familial hypercholesterolaemia -- an inherited cholesterol disorder that raises the risk of heart disease -- should be screened by age 10. The guidance is also expected to push for the introduction of cascade screening, or family testing, for the condition.