Keyword: Bethany Hills

Medical device recalls have hit record highs in 2018, and software is largely to blame.

The digital health industry waited six years for the FDA to release CDS guidance. Now that it's here, some say the agency didn't push far enough.

The FDA has outlined basic concept of its new software precertification program, but companies selected for the pilot will have an outsized influence.

A new pilot program lays the groundwork for the FDA to overhaul its approach to regulating digital health companies that "fosters, not impedes, innovation."

President Donald Trump wants to increase FDA medical device user fees by more than $300 million in 2018, raising muted concern from the digital health industry.

Under Scott Gottlieb, the FDA is likely to undergo a subtle policy shift that could be beneficial for the digital health industry.