FDA Clears the Individualized Nomogram for Rika Plasma Donation System

SciFocus/May 2024 -- Terumo Blood and Cell Technologies (Terumo BCT), a leader in medical technology, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rika Plasma Donation System? featuring the iNomi? Nomogram. This innovative advancement is designed to optimize plasma collection volumes based on individual donor characteristics such as height, weight, and hematocrit levels, enhancing efficiency without increasing collection time.

Key Highlights:

- Personalized Plasma Collection: The iNomi? Nomogram tailors plasma collection volumes to each donor's height, weight, and hematocrit level, ensuring more precise and effective plasma donations.

- Efficient Collection Process: The Rika Plasma Donation System can complete plasma collections in 35 minutes or less, maintaining a maximum of 200 milliliters of blood outside the donor's body at any time.

- Improved Donor Comfort and Safety: Rika's advanced control system guides operators, enhancing donor safety and comfort throughout the donation process.

- Increased Plasma Collection Volume: Clinical trials demonstrated a 10% increase in plasma volume collected per donation without extending the average collection time.

- Support for Plasma-Dependent Patients: Plasma donations are crucial for treating conditions like primary immune deficiencies, requiring approximately 130 donations annually for a single patient.

- Streamlined Operations: The Rika system, including the Myata? Customer Service Portal and Kinari? Device Management Platform, aims to improve productivity and efficiency in plasma collection centers.

Terumo BCT President and CEO, Antoinette Gawin , emphasized the company's commitment to innovation and improving patient care, stating, "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."

Michelle Meyer, VP Plasma Global Operations at CSL Plasma, expressed enthusiasm about implementing the individualized nomogram across their centers, highlighting the commitment to donors, employees, and patients.

About Terumo Blood and Cell Technologies:

Terumo BCT is dedicated to developing medical technology products that enable the collection and processing of blood and cells to treat challenging diseases. With global headquarters in Lakewood, Colorado, and operations in over 150 countries, Terumo BCT continues to drive innovation in the medical technology field.

For more information, visit https://www.pptaglobal.org/donate.

Terumo Blood and Cell Technologies

Website https://www.terumobct.com

If you're enjoying this content, sign up to SciFocus daily newsletter by Biopatrika for all the biggest stories in Science, healthcare, STEM, startups, and how we're advocating to "Bring Science to Society."

For partnership or advertisement opportunities, feel free to contact us here or visit www.biopatrika.com.

Career Opportunities: Biopatrika Career Hub https://www.dhirubhai.net/groups/13946324/

Follow Virender Singh and Biopatrika on LinkedIn.