FDA Revokes EUA for Blood Filter Device
The U.S. Food and Drug Administration revoked the Emergency Use Authorization for the Seraph 100 Microbind Affinity Blood Filter. The device, made by ExThera Medical Corporation, had been authorized for emergency use during the COVID-19 pandemic. The revocation reflects the evolving standards and data requirements for medical devices as the public health emergency has subsided.
- The revocation was formally requested by the device's manufacturer, ExThera Medical Corporation, on October 21, 2025, and as of the revocation date, no devices remained in distribution under the emergency authorization. - The Seraph 100 filter operates on a principle of biomimicry; it contains beads coated with heparin, which mimics the surface of human cells, to attract and bind to a wide range of pathogens like bacteria and viruses, removing them from the bloodstream. - Development of the Seraph technology was supported by funding from the Defense Advanced Research Projects Agency (DARPA) with the initial goal of treating sepsis in soldiers. - Clinical data for its use in COVID-19 patients has been mixed; one observational study of 99 patients showed a mortality rate of 37.7% in treated patients compared to 67.4% in the control group. However, a different retrospective study found that while treated patients were less likely to die, this difference was not significant in a post-hoc analysis. - The device received a CE Mark for use in the European Union in 2019, predating its emergency use for COVID-19 in the United States, for the reduction of pathogens in bloodstream infections. - Although the COVID-19 emergency authorization is revoked, ExThera Medical continues to investigate the Seraph 100 for other applications and is enrolling patients in a new clinical trial funded by the Department of Defense to evaluate its effectiveness in treating sepsis. - The company is also exploring the device's potential in oncology, with laboratory studies suggesting it can remove tumor-associated microparticles from the blood of pancreatic cancer patients.
