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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Haemonetics' NexSys PCS Plasma Collection System With Persona PLUS

The updated donor-tailoring technology collected a mid-single-digit percent more plasma per donation than its predecessor in a trial of nearly 3,000 donors, the company said.

By News DeskFebruary 25, 20262 min read
A clear bag containing one unit of frozen yellow blood plasma
A bag holding one unit of fresh frozen plasma. Plasma collection systems such as NexSys PCS separate plasma from donated blood. DiverDave, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA cleared510(k)FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared the NexSys PCS Plasma Collection System with Persona PLUS Technology under 510(k) BK251292 on February 20, 2026; Haemonetics announced it on February 23.
  • Persona PLUS is the next version of Haemonetics' Persona technology, which tailors each plasma collection to the individual donor.
  • Haemonetics said a randomized pivotal trial of more than 30,000 donations from nearly 3,000 donors showed an average mid-single-digit percent increase in plasma per donation over Persona.

Haemonetics has received US Food and Drug Administration 510(k) clearance for its NexSys PCS Plasma Collection System with Persona PLUS technology, an update to the technology its plasma collection machines use to tailor each collection to the donor, the company said on February 23 in a release distributed by PR Newswire, read via Finviz.

The clearance was issued through the FDA's vaccines, blood and biologics program. Its 510(k) record lists the clearance as BK251292, with a decision date of February 20, 2026.

What the FDA cleared

According to the 510(k) summary, the NexSys PCS separates whole blood by centrifugation, collects the plasma and returns the remaining components to the donor. The plasma may be used for transfusion or as source plasma that is fractionated into plasma-derived products.

The summary says there is no change to the system's indications for use, and no change to its material, composition, principle of operation or energy source compared with the predicate, an earlier NexSys PCS cleared as BK220798, and no change to the product's software specific to introducing Persona PLUS. The NexSys PCS with the original Persona technology, BK200498, is also listed as a predicate. No new non-clinical testing was required, the summary says.

Instead, the clearance rested on a prospective, randomized, controlled, multicenter pivotal trial. The FDA summary concludes that the data show "no change to the benefit-risk profile" of the device with the introduction of Persona PLUS.

The company's results

Haemonetics said the trial involved more than 30,000 plasma donations from nearly 3,000 donors, and that Persona PLUS delivered on average a mid-single-digit percent increase in plasma per donation compared with Persona. The company did not give a precise figure in its release.

"With the growing demand for plasma-derived therapies, plasma collectors' need for innovation to scale operations efficiently and cost-effectively has never been greater," said Roy Galvin, Haemonetics' executive vice president and chief commercial officer. He said Persona PLUS extends the company's position in delivering solutions that lower cost per liter.

Haemonetics describes itself as the global leader in the plasma collections market. Its Persona technology tailors collection volumes to each donor's characteristics, and the clinical data showed measurable improvements in plasma yield per donation session, Clinical Lab Products reported. The company did not say in the release when Persona PLUS would be available to plasma collection centers.

Sources

  1. Haemonetics Receives FDA Clearance for NexSys PCS Plasma Collection System with Persona PLUS Technology (PR Newswire release, read via Finviz), Haemonetics (via Finviz), February 23, 2026
  2. BK251292 - NexSys PCS Plasma Collection System with Persona Plus Technology (page as updated 2026-02-24; facts cited were in the 2026-02-20 decision), US Food and Drug Administration, February 24, 2026
  3. 510(k) Summary, BK251292, US Food and Drug Administration, February 18, 2026
  4. FDA Clears Haemonetics' NexSys PCS Persona PLUS Plasma Collection System, Clinical Lab Products, February 25, 2026