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FDA warns medical device maker about clinical trial, premarket violations

A photo of two clinicians in personal protection emergency suits looking at blood samples.
Photo: Gaston Brito/Getty Images

Kevin Kinsella

3 min read
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According to the regulator, ExThera Medical sent its Seraph 100 blood filters to a hospital for emergency/compassionate use without first obtaining permission.

A warning letter has been issued to ExThera Medical Corporation for distributing its product to a hospital for compassionate use (CU) without premarket approval.

In the communication, penned by the US Food and Drug Administration (FDA) on February 6, 2026, the California-based medical device maker was also put on notice

According to

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