Yahoo

Serenity Medical secures FDA humanitarian exemption for cerebral venous stent

Add Yahoo as a preferred source to see more of our stories on Google. The US Food and Drug Administration (FDA) has granted Serenity Medical’s River stent a humanitarian device exemption (HDI), making ...
Seeking Alpha

Artivion Granted FDA Humanitarian Device Exemption for the AMDS Hybrid Prosthesis

ATLANTA, Dec. 9, 2024 /PRNewswire/ -- Artivion, Inc. (AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) ...
Healio

Real-world data: Therapeutic device safe, may benefit sepsis-associated pediatric AKI

Please provide your email address to receive an email when new articles are posted on . The device received FDA humanitarian device exemption status in 2024. Survival rate for children treated with ...
RAPS

FDA Finalizes Guidance on Devices Intended for Use in Rare Diseases

The US Food and Drug Administration (FDA) has announced the release of a new guidance document intended for both its staff and the medical device industry pertaining to the issuance of humanitarian ...
Hosted on MSN

Serenity Medical secures FDA humanitarian exemption for cerebral venous stent

The US Food and Drug Administration (FDA) has granted Serenity Medical’s River stent a humanitarian device exemption (HDI), making it the first cerebral venous stent approved by the agency for the ...