Page 2 - Breakthrough Devices News Today

In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns...

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies...

The SNOO is the first sleep product to earn FDA De Novo approval for safely keeping babies on their backs while they sleep. Back sleeping significantly lowers the risk of SIDS, according to experts.

From the blog of Lili Eylon at The Times of Israel

The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health...

The FDA has developed draft guidance to propose select updates to the FDA guidance document, “Breakthrough Devices Program.”

On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency's 2018 guidance on its Breakthrough Devices Program...

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA updated the...

Genomic testing company Variantyx raised $20 million in debt financing, and mental health provider Mindful Care scooped up $7 million.

DAIC editors outline some highlights of what to expect from this year’s conference