Page 4 - Devices Program News Today

PRINCETON, N.J., Dec. 28, 2023 -- CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its...

/PRNewswire/ - ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable...

Thousands of qualifying households in Frederick County will receive free laptops paid for by a grant from the Maryland Department of Housing and Community Development.

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 ...

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs.

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If...

On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff."

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...

Annalise.ai, a leader in AI-powered medical imaging solutions, announced the receipt of 510(k) clearance from the U.S. Food and Drug Adm…

First ever radiology triage device to be awarded this status under the FDA Breakthrough Devices Program