Dec 2, 2016 | Medical Devices
The US Food and Drug Administration (FDA) has released final guidance for reporting and record-keeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions. The FDA says the purpose of the updated...
Mar 18, 2016 | Medical Devices, Products Liability
The FDA (Food and Drug Administration) said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is designed to call attention to serious or life threatening risks...
Mar 15, 2016 | Medical Devices
A recent study has found that women who routinely talcum powder around their genitals increase their risk of ovarian cancer by 33%. The report obtained the results by asking over 2000 women with ovarian cancer and 2100 women without ovarian cancer about their usage...
Feb 5, 2016 | Medical Devices
An IVC filter is a medical device designed to prevent blood clots from traveling to the lungs. The device is implanted into the largest vein in the body leading from the lower extrmeties to the heart. The filter is used for patients who are at risk for deep vein...
