Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX

Source Summary

TORONTO, June 25, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the U.S. Food and Drug Administration (“FDA”) has completed its filing review and formally filed the Company's Premarket Approval (“PMA”) application for PMX, the Company’s endotoxin removal therapy for patients with endotoxic septic shock (“ESS”).