Draft guidance from the Food and Drug Administration is seeking to clarify when medical device manufacturers need the agency’s approval to make changes to their products, potentially replacing guidance that had remained unchanged since 1997.

Hospitals were paid about 8 percent less by Medicare Advantage plans compared to traditional fee-for-service (FFS) reimbursement in 2009, 2011 and 2012, according to a study published in Health Affairs.

PITTSBURGH, Aug. 03, 2016 (GLOBE NEWSWIRE) -- Two accomplished CEOs – one from the health care industry and the other from the pharmaceutical field – have joined forces to launch Velocity Fund Partners, a private equity fund targeting the life sciences and health care services sector within the health care industry.

The National Institutes of Health (NIH) has permanently closed its facility which manufactured investigational drugs a year after “a series of deficiencies” were found in the unit by Food and Drug Administration (FDA) inspectors.The National Institutes of Health (NIH) has permanently closed its facility which manufactured investigational drugs a year after “a series of deficiencies” were found in the unit by Food and Drug Administration inspectors.

The California Medical Association (CMA) is opposing a bill which would allow certified nurse-midwives to practice without physician supervision, but not because of the main goal of the legislation, according to Kaiser Health News.

Anthem may get its wish for a ruling by year's end in the antitrust case against its $48 billion acquisition with Cigna, as a new judge will preside over the case, potentially speeding up the trial process for the contested Aetna-Humana deal as well.

The fight against Zika continued to pick up steam this week after reports of 15 local transmissions in Miami. 

A September 24 deadline set by the Food and Drug Administration is looming for Class II medical devices, such as condoms or wheelchairs, to be outfitted with unique device identifier (UDI) barcodes, but in a survey of device makers, only a few said their companies were currently compliant with the standard.