Posted by Michael Wonder on 11 Jul 2022
US FDA grants Spectral Medical breakthrough device designation for Toraymyxin for the treatment of endotoxemic septic shock
11 July 2022 - Breakthrough designation expected to help accelerate regulatory review.
Spectral Medical today announced that the US FDA has granted breakthrough device designation for the company’s Toraymyxin device, a therapeutic haemoperfusion device that removes endotoxin, which can cause septic shock.
