The FDA 510(k) clearance provides the necessary pre-market approval for Haemonetics to deploy the updated system, certifying it as substantially equivalent to existing legally marketed devices. This regulatory milestone allows the medical technology company to introduce its latest software enhancements to the broader healthcare market.

Optimizing Donor Yields

The Persona PLUS technology represents an evolution of the company’s existing donor-tailored systems. By adjusting the collection process to the specific physiology of each individual, the system achieves a higher average plasma volume per donation. This precision is intended to help collection centers meet the rising global demand for plasma-derived therapies, which are used to treat various rare and chronic conditions.

Haemonetics Chief Commercial Officer Roy Galvin stated that the innovation addresses the urgent need for collectors to scale operations both efficiently and cost-effectively. According to the company, the NexSys PCS with Persona PLUS is designed to lower the cost-per-liter for operators while enhancing safe yields, reinforcing the firm’s competitive position in the medical device industry.