Spectral Medical wins FDA nod for Spectral Apheresis Machine
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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The post Spectral Medical wins FDA nod for Spectral Apheresis Machine appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Fink Densford Tags: 510(k) Drug Pumps Food & Drug Administration (FDA) Regulatory/Compliance Spectral Medical Inc Source Type: news
More News: Intensive Care | Septic Shock