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Home » FDA clears Haemonetics next-gen autotransfusion system software

FDA clears Haemonetics next-gen autotransfusion system software

March 2, 2023 By Sean Whooley

Haemonetics Cell Saver Elite+ autotransfusion system
The Cell Saver Elite+ system. [Image from Haemonetics]
Haemonetics (NYSE:HAE) announced today that it received FDA 510(k) clearance for next-generation software for the Cell Saver Elite+ autotransfusion system.

Boston-based Haemonetics began a full market release for the software update, named Intelligent Control. It designed the software to offer key enhancements to simplify operations, support efficiency and improve user experience.

Cell Saver Elite+ allows hospitals to recover a patient’s blood in surgical procedures. These procedures have the potential for medium to high blood loss, Haemonetics said in a news release. It helps to avoid unnecessary allogeneic transfusions while reducing related costs.

Procedures with the potential for high blood loss include cardiac, orthopedic, trauma, transplant, vascular and OBGYN surgeries. Haemonetics designed the system to recover blood, wash it and deliver it to a product bag.

According to Haemonetics, the system’s new software offers more than 50 automation enhancements. These include complete user control with a “manual mode” option, expanded wash volumes and enhanced emergency options.

“This latest upgrade represents a significant advancement in our Cell Salvage platform and builds upon our nearly 50-year foundation as the leader in autotransfusion. The Intelligent Control software enhances our SmartSuction and Latham bowl technologies to help maximize the recovery of red blood cells,” said Stewart Strong, president of global hospital at Haemonetics. “With the new software for the Cell Saver Elite+, we are delivering customers more versatility and simplicity to best meet their autotransfusion needs.”

Filed Under: 510(k), Blood Management, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT Tagged With: Haemonetics

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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