Spectral Medical (TSX:EDT) said this month it won FDA 510(k) clearance for its Spectral Apheresis Machine designed for use in continuous renal replacement therapy and therapeutic plasma exchange.
The SAM device was developed to support commercialization of the company’s Toraymyxin, or PMX therapy, to enable intensive care units to be able to safely and efficiently deliver PMX treatments to patients undergoing septic shock.
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