Bluejay Reports FDA Agrees to Consider Its Plan to Pursue A De Novo Regulatory Pathway for the Symphony II-6 Test

Bluejay Diagnostics, Inc. announced that the FDA has agreed to consider Bluejay's plan to pursue a De Novo submission for the Symphony IL-6 Test. In written feedback to the January 2022 submission of the FDA pre-submission briefing package, the FDA stated that Bluejay's Symphony IL-6 Test could be considered for the De Novo pathway.