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Medical Devices / Submissions and Approvals

FDA Clears Spectral Medical Stand-Alone Pump

Dec. 27, 2017

The FDA granted 510(k) clearance to Spectral Medical’s Spectral Apheresis machine for use in therapeutic plasma exchange and continuous renal replacement therapy (CCRT).

The stand-alone pump was initially developed for use in intensive care units to septic shock patients without requiring third-party CCRT machines.

The company said it will seek clearance for use of the Apheresis as an open platform hemoperfusion delivery device once an FDA-approved hemoperfusion cartridge is available on the market.

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