FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a...

NeuroOne® Provides Progress Update on FDA 510(k) Submission for OneRF™ Ablation System Feedback from responses to FDA anticipated in 30 days Commercialization remains on track in first half of 2024 pending FDA clearance Product potential for transformative improvement in...