Medical Devices
Guidelines on how certain mobile medical apps will be governed by the U.S. Food and Drug Administration may be released as soon as the end of the year.
The Food and Drug Administration (FDA) released a proposed rule that most medical devices distributed in the United States carry a unique device identifier (UDI).
The U.S. House of Representatives approved a bill Wednesday to increase user fees paid by pharmaceutical and medical device manufacturers looking to bring new products to the market. The bill passed easily by a vote of 387-5.
According to a recent report by the Health Research Institute at PwC U.S. regarding the use of social media in healthcare, one-third of consumers use sites such as Facebook, Twitter, YouTube and online forums to find health-related information.
In 2011, the medical device sector posted a total of 170 deals, according to Deal Search Online, the M&A database from Irving Levin Associates. And according to revealed prices, 2011 had a grand total of $63.5 billion in medical device merger and acquisition transactions. We delved a bit deeper into the five largest medical device M&A deals of 2011, as outlined by Irving Levin Associates.
Medical device manufacturers are feeling the effects of a sluggish economy and a revamped reimbursement model, which are leading to slow growth and record levels of mergers and acquisitions activity.
The U.S. Department of Health and Human Services needs to strengthen its oversight capacity, according to the Office of Inspector General's annual summary of management and performance challenges facing the agency.
Providers offer options for the Supercommittee to cut Medicare costs by making better coverage decisions and discouraging routine unnecessary services.
On October 7, 2011, the Centers for Medicare & Medicaid Services and the Food and Drug Administration announced they are soliciting nominations from sponsors of medical devices to participate in a parallel review pilot program.
The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have launched a parallel review pilot program that allows medical devices to be reviewed for approval by the FDA and CMS at the same time.