Medscape

FDA Grants Humanitarian Use Device Designation for Diaphragm Pacing System in ALS

October 14, 2010 — The US Food and Drug Administration (FDA) has granted humanitarian use device designation for a diaphragm pacing system (NeuRx; Synapse Biomedical, Inc) in patients with amyotrophic ...
Becker's ASC

FDA Issues Draft Guidance on Humanitarian Use Device Classification

The FDA released a draft guidance on the submission process for humanitarian use device designation for devices that diagnose or treat diseases and conditions effecting fewer than 4,000 Americans per ...
Nasdaq

Artivion Granted FDA Humanitarian Device Exemption for the AMDS Hybrid Prosthesis

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

SeaStar Medical Finalizes FDA Labeling Requirement for QUELIMMUNE, Paving the Way for First Commercial Sales as Humanitarian Use Device

DENVER, July 03, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of ...

SeaStar Medical Announces 2026 Milestones

Drive adoption of QUELIMMUNE for ultra-rare pediatric AKI, expanding revenue and doubling the customer baseAdvance SeaStar Medical’s ...
unr.edu

120. Investigational Device Research and Exempted Device Investigations

For research involving medical devices, the University IRB will comply with the requirements set forth in 21 CFR Part 812. Per FDA regulations at 21 CFR 812, FDA’s regulations specify the ...