FDA Grants SeaStar Medical Breakthrough Device Designation for its SCD Therapy for the Treatment of Hyperinflammation in Adult Patients with Sepsis or a Septic Condition
SeaStar Medical (ICU) received FDA Breakthrough Device Designation for its SCD therapy to treat hyperinflammation in adult sepsis patients. This designation accelerates development and review. Sepsis affects 1.7M U.S. adults annually, with high mortality rates. The company plans to submit data to the FDA soon. This is the seventh such designation for the SCD therapy across various indications.
