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Home » Haemonetics gets FDA nod for next-gen plasma collection system

Haemonetics gets FDA nod for next-gen plasma collection system

February 24, 2026 By Sean Whooley

Haemonetics NexSys PCS (1)
The NexSys PCS system. [Image courtesy of Haemonetics]
Haemonetics (NYSE: HAE) announced that it received FDA clearance for its NexSys PCS plasma collection system with Persona PLUS technology.

Persona PLUS represents the next generation of the Haemonetics proprietary and patented Persona technology. Its platform tailors plasma collection to each donor for improved average plasma volume per donation.

Boston-based Haemonetics won an initial FDA 510(k) clearance for its NexSys platform in 2017. It picked up clearance for NexSys Persona in 2020, then added further enhancements through a 2023 clearance. The company supported its latest addition to the portfolio with a pivotal trial involving more than 30,000 plasma donations from nearly 3,000 donors. This study demonstrated the safety and effectiveness of the system and highlighted a mid-single-digit percent increase of plasma per donation compared to the previous Persona offering.

Haemonetics describes itself as the global leader in the plasma collections market. It labeled NexSys PCS as the industry’s most advanced, completely integrated system. It streamlines plasma collections while delivering lower cost-per-liter through improved yield, productivity, safety, quality, compliance and donor satisfaction, the company says.

“With the growing demand for plasma-derived therapies, plasma collectors’ need for innovation to scale operations efficiently and cost-effectively has never been greater. Persona PLUS extends Haemonetics’ leadership in delivering solutions which lower cost-per-liter and enhance yields safely,” said Roy Galvin, EVP and CCO at Haemonetics.

Filed Under: Business/Financial News, Food & Drug Administration (FDA), Regulatory/Compliance 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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