Terumo Blood and Cell Technologies has received US Food and Drug Administration (FDA) 510(k) clearance for its Rika Plasma Donation System™, now equipped with the iNomi™ Nomogram. 

This development marks a key advancement in plasma collection technology, allowing for the determination of plasma collection volume based on an individual donor's height, weight, and hematocrit level at the time of donation.

Renowned for its extensive portfolio of medical devices dedicated to blood and cell processing, Terumo BCT introduces Rika as the next-generation plasma collection system tailored for application in plasma collection centers.

Antoinette Gawin, President and Chief Executive Officer of Terumo Blood and Cell Technologies, expressed the company's commitment to innovation in the plasma industry, remarking, "Terumo BCT continues to innovate for the plasma industry, setting new standards and expanding patient access to care. 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 incorporation of the individualized nomogram is projected to elevate collection volume without prolonging collection time. A clinical trial conducted to support the recent FDA clearance revealed an average 10 percent increase in plasma collection volume per donation, with an average collection time of less than 35 minutes.

The development team at Terumo BCT focused their efforts on leveraging technology and addressing the needs of plasma donors and collection center staff. With a collection time of 35 minutes or less and a volume of 200 milliliters or less of blood outside the donor's body, the Rika system promises a more comfortable donation experience. Moreover, Rika's advanced control system enhances donor safety by continuously monitoring the process and providing alerts and visual cues to guide operators. Automatic adjustments during each procedure ensure a seamless operator experience and allow for more personalized interaction with donors.

Michelle Meyer, Vice President of Plasma Global Operations at CSL Plasma, expressed enthusiasm for the introduction of the individualized nomogram, stating, "CSL Plasma looks forward to the rollout of the individualized nomogram as we continue to introduce the Rika Plasma Donation System to our close to 330 centers in the United States. We are eager to implement this latest innovation from Terumo that supports our dedication to our donors, employees, and delivering on our promise to our patients."

Representing a leap forward in plasma collection practices, Rika was initially cleared for use by the FDA in March 2022. As part of an extensive ecosystem including the MyataTM Customer Service Portal and the KinariTM Device Management Platform, which facilitates electronic software distribution, this innovation is poised to enhance center productivity and efficiency. Ultimately, the goal is to optimize plasma collections and meet the critical needs of patients afflicted with life-threatening illnesses who depend on plasma-derived therapies.