2013

If you still use an inhaler that utilizes chlorofluorocarbons, then it’s imperative that you speak with a doctor to obtain an alternate product as soon as possible.  As the Food and Drug Administration notes in a new report, these types of items are about to become a thing of the past by the end of… read more

The Food and Drug Administration has given its approval to a test that is supposed to allow for more expedient testing procedures that should enable doctors to treat patients suffering from illnesses related to yeast or bacteria more quickly.  The new mass spectrometer system, which goes by the name VITEK MS, is purported to be… read more

The Food and Drug Administration has issued a warning to healthcare providers explaining to them that the instructions for use of the Stryker Wingspan Stent System have changed.  Used to widen the narrowed arteries of the brains of repeated stroke victims, these stents should, according to the FDA, only be used in a certain subset… read more

The Food and Drug Administration has granted approval to pills from Proteus Digital Health that can alert a patient to when they’ve forgotten to take their medication.  The pills contain a microchip the size of a grain of sand that can relay whether a pill has been ingested to a sensor placed on a person’s… read more

Earlier this week, the United States House of Representatives passed legislation that, if enacted, would provide additional funding and authority to the Food and Drug Administration. The bill, passed by a bipartisan vote of 387 for, 5 against, is intended to give the FDA the resources and power to prevent shortages of medication and review… read more

We often think about how devastating a cyberattack or viral infection can be for our computers.  But could similar tactics be used by hackers to compromise the safety of medical devices? The general consensus seems to be that such a hack is indeed possible, which is why the National Institute of Standards and Technology and… read more

A battle is shaping up between the makers of a medical device and a doctor who is saying that a defect in the device directly contributed to the death of more than 20 people. In the March issue of the Heart Rhythm Journal, a medical journal, a doctor has written a report about St. Jude… read more

First came the recalls that were initiated against hip implants and infant Tylenol made by subsidiaries of Johnson & Johnson.  These were owing to serious safety concerns with the products.  Now, another potential Johnson & Johnson company is being warned of its product’s deficiencies by the Food and Drug Administration. The FDA fired off a… read more

News sources report, that Medtronic Inc. issued a class 1 recall Monday of its SynchroMed II implantable drug infusion pump, making this the second such recall of the product this year. The recalled pumps have an issue with the battery that can lead to sudden failure of the device. Class 1 recalls are reserved for… read more

The U.S. Food and Drug Administration announced in a news release Friday that Vital Signs Devices, a GE Healthcare Company, has initiated what the company is calling a “voluntary worldwide field correction” of a medical humidifier due to a defect that may cause insufficient oxygen to reach a patient. The field correction, which the FDA… read more

News sources say that, according to the FDA, in 2010, doctors performed more than 100,000 prolapse repairs using surgical mesh, and about 75 percent of them were transvaginal. Between 2005 and 2007, the agency received more than 1,000 reports of adverse events related to the mesh in women diagnosed with pelvic organ prolapse or stress… read more

Janet Holt told media sources that she believed she just had some sort of infection “down there.” But her doctor told her that she was in need of an operation, explaining that her bladder had slipped out of place and created an uncomfortable condition called pelvic organ prolapse, which is common among women as they… read more