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Canadian Health Authority Grants ExThera’s Seraph 100 Blood Filter an Interim Order for Treatment of COVID-19

by Keith Underwood | Aug 9, 2021 | Uncategorized

ExThera Expands Distribution of Blood Purification and Pathogen Reduction Treatment for Sepsis and COVID-19 in Europe – ExThera Medical and Fresenius Medical Care to offer Seraph 100 Microbind Affinity Filter in Turkey, Finland, and Estonia

by Keith Underwood | Jul 28, 2021 | Uncategorized

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    The Seraph 100 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

    The ONCObind™ Procedure Hemoperfusion Filter is approved for Investigational Device Exemption (IDE) study and is not commercially available.

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