On October 5, 2018, the FDA granted Bose Corporation authorization to market the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program, and control the hearing aid on their own, without assistance from a health care provider. Click title to continue reading...
On October 1, 2018, FDA Commissioner Scott Gottlieb, M.D., issued a statement on the FDA’s efforts to strengthen the FDA’s medical device cybersecurity program. Even when medical devices are not being deliberately targeted, devices such as radiologic imaging equipment may be impacted if connected to a hospital network. Click title to continue reading...
On October 5, 2018, the CDC published a report that found that the 2018 cyclosporiasis outbreak season was noteworthy for multiple outbreaks associated with different fresh produce items and the large number of reported cases. A total of 2,299 domestically acquired, laboratory-confirmed cases were reported in persons who became ill during May through August 2018, which was markedly higher than the numbers of cases reported for the same period in either of the last two years. Click title to continue reading...