Insights - HcFocus

The Complexities of Navigating the FDA Breakthrough Devices Program

Devices that qualify for Breakthrough Device designation often involve an ambitious clinical claim, a novel

Getting a Category III code is often considered a milestone on the path to reimbursement.

Securing a Breakthrough Device designation from the FDA is significant, but it is only the

Medicare’s traditional approach to reimbursement makes it difficult for hospitals and physicians to use innovative

If prior authorization is making it hard to get your medical innovation to patients, you’re not alone.

For medical device, test, and technology innovators, one of the earliest and most important questions

Bringing a new medical device, test, or technology to market is no small feat. Between

Bringing a medical device or diagnostic test to market is no small feat—but getting reimbursed

In the US healthcare system, the path to widespread adoption of innovative medical technologies hinges

The world of biotech is brimming with groundbreaking discoveries. But translating that potential into a