FDA Approves Spectral's Third PMA Module for Toraymyxin Treatment of Endotoxemic Septic Shock
Toronto–based Spectral received approval from the FDA for the third module of its rolling PMA submission from the FDA for Toraymyxin (PMX).
PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream.
The third PMA module details the device description and principles of operation and manufacturing processes, including risk management and quality system integration. — Cynthia Jessup