RegulatoryCompany release

FDA says SeaStar's registry satisfies post-approval study duty for paediatric kidney device QUELIMMUNE

🇺🇸 SeaStar Medical Holding Corp (ICU) · Tue 03 Nov 2026

CBER has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry fulfils the post-approval study requirements attached to the device's Humanitarian Device Exemption approval, SeaStar Medical said.

SeaStar Medical Holding Corp said on 3 November 2026 that the US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has found the QUELIMMUNE Pediatric SAVE Surveillance Registry meets the post-approval study requirements of the product's Humanitarian Device Exemption (HDE) approval.

QUELIMMUNE, also known as SCD-PED, is used to treat sepsis-associated acute kidney injury in paediatric patients who are receiving renal replacement therapy.

According to the company, the determination means hospitals can now use the device without the research infrastructure that the registry required. SeaStar said it will nonetheless continue to enrol patients in the registry on a voluntary basis.

By way of context, an HDE allows a device intended for a rare condition to be marketed on the basis of probable benefit, and FDA can attach post-approval conditions to such authorisations. The source material available does not set out the registry's design, size or findings.

What it means for your team

  • Sponsors of HDE devices should note that a registry can be accepted as discharging a post-approval study condition, as it was here, according to SeaStar.
  • Hospital and clinical-engineering teams may find access simpler, as use no longer depends on the registry's research infrastructure.
  • Continued voluntary enrolment means some real-world data collection should carry on, though its scope has not been specified.
  • Teams tracking the product should seek the formal FDA determination, as the details here rest on the company's account.

Company's press release (SEC filing): SeaStar Medical Holding Corp ↗

Article written by VigiEye from the official source (SeaStar Medical Holding Corp). Claims are the company's own. AI-assisted; check the source before acting.

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