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Tag Archives: Terumo BCT—

FDA clears seven-day platelet storage, wireless option, 10/15

Terumo BCT has received 510(k) clearance for a labeling change, extending the storage of platelets in plasma from five days to seven days, as well as offering wireless capability for the software applications used with Terumo BCT’s Trima Accel Automated Blood Collection System. This clearance adds to the flexibility and productivity of the Trima Accel system, a device that offers single-needle procedures for a more comfortable donation experience.

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Software 2.0 for Quantum, 3/14

March 2014—Terumo BCT released Quantum Software 2.0, updated and enhanced software for the Quantum Cell Expansion System, as part of its ongoing goal to aid cell-therapy companies and research organizations in current Good Manufacturing Practices and in compliance with part 11 of the Code of Federal Regulations.

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DoD contract for Terumo, 1/14

January 2014—Terumo BCT has been awarded a U.S. Department of Defense cost-share contract worth up to $29.9 million to advance the Mirasol system for the treatment of donated whole blood used in emergency transfusions to deployed military personnel.

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FDA clears SN-TPE on Terumo system, 11/13

Terumo BCT has received FDA 510(k) clearance for single-needle therapeutic plasma exchange (SN-TPE) on its Spectra Optia apheresis system. This option gives therapeutic apheresis operators the ability to convert to SN-TPE at the beginning or at any time during the procedure, depending on patient needs.

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