Breakthrough Devices News Today

Discover the nominees for the best affordable premium smartphone of the year at the Times of India-Gadgets Now Awards. Find out why these smartphones were chosen and their impact on Indian consumers' lives. Don't miss this exciting event!

LOS ANGELES--(BUSINESS WIRE)--Jan 3, 2024--

/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...

On September 15, 2023, FDA released a final guidance document titled "Breakthrough Devices Program." Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program ...

The agency seeks to draw on outside expertise to "ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation," says the director of its Center for Devices and Radiological Health.

We remember the late Jimmy Buffett who sang in his 1977 classic, “Changes in latitudes, changes in attitudes; Nothing remains quite the same.” Demonstrating a change in attitude, in...

CytoSorbents Reports Second Quarter 2023 Financial and Operational Results Q2 2023 Total Revenue was $9.4 million, an 11% increase from $8.5...

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly...

On June 27, 2023, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a “Notice with Comment Period” (“Notice”) describing a new process for providing expedited...

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a long-awaited procedural notice with comment period (CMS-3421-NC) that outlines a proposed Transitional Coverage...