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Bluejay Diagnostics, Inc. 8K

0001213900-26-080474

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Bluejay Diagnostics completed ahead of plan the 750-patient enrollment in its pivotal SYMON-II study of the Symphony IL-6 sepsis mortality risk test, advancing its regulatory and commercialization strategy.

Bluejay Diagnostics, Inc. announced that it has successfully completed enrollment, ahead of schedule, of 750 patients in its pivotal SYMON-II multicenter clinical validation study evaluating the Symphony IL-6 rapid diagnostic test for early assessment of 28‑day sepsis mortality risk in ICU patients, providing a robust dataset expected to support forthcoming data analysis, regulatory submissions (including a planned 510(k) to the FDA), and eventual commercialization efforts for the Symphony platform.

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1704287
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8K
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sec
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0001213900-26-080474
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6
Bluejay Diagnostics, Inc. 8K | ATTN