SeaStar Medical wins FDA Breakthrough Device designation for sepsis hyperinflammation therapy
ICU•The FDA granted Breakthrough Device Designation to SeaStar Medical’s SCD therapy for hyperinflammation in adult sepsis patients. The designation supports an accelerated regulatory pathway as the company prepares to present data from a NEUTRALIZE-AKI pivotal trial subset; it is the SCD platform’s seventh such designation.
1. FDA designation
The FDA granted Breakthrough Device Designation to SeaStar Medical’s SCD therapy targeting hyperinflammation in adult sepsis patients. The designation supports an accelerated regulatory pathway as the company prepares to present data from a NEUTRALIZE-AKI pivotal trial subset, and marks the SCD platform’s seventh Breakthrough Device Designation across multiple indications.
