FDA lowers surveillance requirement to 50 patients for QUELIMMUNE approval.
ByAinvest
Tuesday, Dec 2, 2025 8:38 am ET1min read
ICU--
The FDA has approved a reduction in the mandatory enrollment size of the SAVE Surveillance Registry from 300 patients to 50 patients. This change is based on the assessment of the first 21 patients in the registry. The decision suggests that the FDA believes continued device safety can be shown with fewer patients than originally required, expanding the market opportunity for QUELIMMUNE.
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