FDA Files Spectral Medical PMX PMA
Analysis based on 6 articles · First reported Jun 25, 2026 · Last updated Jun 25, 2026
The filing of the PMA application by the United States — Food and Drug Administration for Spectral Medical's PMX therapy is a significant positive development for Spectral Medical, potentially leading to market approval and increased revenue. This could also positively impact the broader medical device and biotechnology industries by offering a new treatment for septic shock.
Spectral Medical announced that the U.S. United States — Food and Drug Administration has formally filed its Premarket Approval (PMA) application for PMX, an endotoxin removal therapy for patients with endotoxic septic shock. This filing signifies that the application contains all necessary information for substantive review. The PMA application is supported by positive results from the Tigris trial, which demonstrated a significant probability of benefit for 28-day and 90-day all-cause mortality. PMX has already received Breakthrough Device Designation from the United States — Food and Drug Administration and is approved for therapeutic use in Japan and Europe, and licensed by Canada — Health Canada. This milestone is crucial for Spectral Medical as it moves closer to potential U.S. market approval for a therapy addressing a critical unmet medical need.
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