The FDA has published the final guidance for its new regulatory pathway aimed at helping medical device manufacturers gain 510(k) approval by meeting certain safety and performance criteria. 

The U.S. government shutdown, which is now the longest-running in history, could potentially harm consumers and undermine the stability of the Affordable Care Act healthcare insurance market, The Wall Street Journal reported.

As progressive Democrats increasingly push for universal healthcare, known as Medicare for all, support for such a plan is mixed when it comes to paying for it, according to a recent poll from the Kaiser Family Foundation.

The trade group for the U.S.'s top drugmakers spent a record amount—$27.5 million—on lobbying efforts in 2018, according to Bloomberg.

More industry groups are pushing back against an upcoming deadline for accountable care organizations (ACOs) to apply to the updated Medicare Shared Savings Program.

Medicare payments in 2019 aren’t likely to cover the cost of delivering care for two-thirds of medical practices, according to a survey from the Medical Group Management Association (MGMA).

"In taking these new steps today, we’re reaffirming our commitment to continually strengthening our review process, so that it can continue to serve and protect American patients well for years to come,” wrote FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health (CDRH), in a recent statement.

The average annual cost of managing type 1 diabetes has skyrocketed, with the rising cost of insulin being a main contributor, according to a new issue brief from the Health Care Cost Institute.