SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI
SeaStar Medical Holding Corporation (ICU)
Company Research
Source: GlobeNewswire
FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients Compelling efficacy data to date along with completion of registry expected to expand QUELIMMUNE market opportunity DENVER, Dec. 02, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has approved a reduction in the mandatory enrollment size of the SAVE Surveillance Registry from the originally-required 300 patients to only 50 patients. This new 50-patient registry size will satisfy the post-approval surveillance requirement by the FDA as outlined in the original Humanitarian Device Exemption (HDE) approval and indicates that FDA believes that continued device safety can be successfully shown with fewer patients than originally required. T
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- SeaStar Medical to Present at Upcoming Noble Capital Markets Emerging Growth Virtual Equity ConferenceGlobeNewswire
- SeaStar Medical (NASDAQ:ICU) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=ICU&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen<MarketBeat
- SeaStar Medical Announces 2026 MilestonesGlobeNewswire
- SeaStar Medical to Present at Upcoming Biotech Showcase 2026 Investor ConferenceGlobeNewswire
- SeaStar Medical Announces 1-for-10 Reverse SplitGlobeNewswire
ICU
Sec Filings
- 1/20/26 - Form 8-K
- 12/23/25 - Form 8-K/A
- 12/22/25 - Form 4
- ICU's page on the SEC website