Medical Devices
When the 2013 International CES opened this past January in Las Vegas, the usual high-tech toys and gadget geeks were in attendance. But tucked into that crowd was a newer market, one that could someday compete with the latest in high-definition TV or souped-up cars for prominence: the healthcare consumer.
On January 8, 2013, the Obama Administration published its latest semiannual regulatory agenda, outlining planned regulatory initiatives in a number of policy areas.
The Department of Justice recently announced that it secured a record $4.9 billion in settlements and judgments in civil fraud cases in FY 2012, including health care fraud recoveries totaling more than $3 billion.
The U.S. Food and Drug Administration (FDA) announced Monday that it is part of the first public-private partnership to promote medical device regulatory science. The partnership will focus on speeding up the review and approval processes of new medical devices.
Healthcare reform is fundamentally changing the way hospitals are run. A combination of crushing costs, government edicts and fierce competition for the millions of newly insured patients that will result from federal healthcare legislation is putting the patient front and center.
The U.S. Department of Health and Human Services (HHS) will need to place a lot of emphasis on implementing the Affordable Care Act (ACA) in the coming year, according to the Office of Inspector General's (OIG) annual summary of management and performance challenges facing the agency, released this week.
Venture capital (VC) funding in the life sciences sector, which includes the biotechnology and medical device industries, decreased 39 percent in dollars and 22 percent in number of deals in Q2 2012 compared with Q2 2011, according to PricewaterhouseCoopers' recent MoneyTree report. Many industry analysts think this downward trend is likely to continue.
In a report released Thursday, the FDA outlined a four-step plan to better monitor and report on the effectiveness and safety of medical devices.
The Food and Drug Administration (FDA) released a proposed rule on July 3 that most medical devices distributed in the United States carry a unique device identifier (UDI).
The cardiac medical device market is projected to reach a compound annual growth rate of an estimated 9 percent by 2015 in the U.S., according to a recent report from research and consultancy firm RNCOS.