REGULATORY UPDATE: Terumo BCT Receives FDA Clearance for Reveos Automated Whole Blood Processing System

Terumo Blood and Cell Technologies received FDA clearance for its Reveous Automated Whole Blood Processing System, according to a recent press release from the company. As described in the release, Reveos is “the first whole blood automation device available in the U.S. that processes whole blood into platelets and other components in a single centrifugation cycle.” 

Currently, more than 90% of platelets transfused in the U.S. come from apheresis donations. The Reveos system provides the capacity to collect platelets from existing whole blood donations and the ability to process the whole blood into platelets, plasma and red blood cells in one centrifugation cycle.

As part of the Reveos clearance, Terumo BCT received an intended use statement for its IMUGARD WB Platelet Pooling Set, which includes platelets prepared by Reveos. The IMUGARD pooling set is FDA-cleared to support the extended shelf of platelets from five days to seven days “when used with FDA-cleared or approved bacterial detection tests.” These platelets can be pooled on day one or day two after collection.