Bluejay, FDA Agree on Plan to Pursue Regulatory Pathway for Symphony IL-6 Test

 Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”, “the Company”), a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today 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.

https://finance.yahoo.com/news/bluejay-reports-fda-agrees-consider-113000242.html