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FDA Clears the Individualized Nomogram for Rika Plasma Donation System

LAKEWOOD, Colo., May 9, 2024 /PRNewswire/ -- Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rika Plasma Donation System™ with the iNomi™ Nomogram. This innovation means that plasma collection volume can be determined by an individual donor's height, weight and hematocrit level on the day they donate plasma.

Terumo BCT makes a broad suite of medical devices that collect, separate and process blood and cells. Rika is the next-generation plasma collection system designed and developed for use in plasma collection centers.

“Terumo BCT continues to innovate for the plasma industry, setting new standards and expanding patient access to care,” said Antoinette Gawin, President and Chief Executive Officer, Terumo Blood and Cell Technologies. “As the need for plasma increases, the Rika ecosystem, now including iNomi, is poised to help meet the demand while offering a potentially more comfortable and efficient experience for plasma donors.”

The individualized nomogram is anticipated to increase collection volume without increasing collection time. The clinical trial to support the recent FDA clearance showed an average 10% increase in the volume of plasma collected per donation with an average collection time of less than 35 minutes.

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