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SeaStar Medical wins FDA Breakthrough Device designation for sepsis hyperinflammation therapy

PUBT·10/07/2026 12:18:02
SeaStar Medical wins FDA Breakthrough Device designation for sepsis hyperinflammation therapy
  • FDA granted Breakthrough Device Designation to SeaStar Medical for its SCD therapy targeting hyperinflammation in adult sepsis patients.
  • Designation supports an accelerated regulatory pathway as the company prepares to present data from its NEUTRALIZE-AKI pivotal trial subset.
  • Marks the seventh Breakthrough Device Designation for the SCD platform across multiple indications.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Seastar Medical Holding Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610070816PRIMZONEFULLFEED9841058) on October 07, 2026, and is solely responsible for the information contained therein.