Bluejay Diagnostics (NASDAQ: BJDX), a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, has announced that the FDA has agreed to consider Bluejay’s plan to pursue a De Novo submission for the Symphony IL-6 Test. “We are excited for the opportunity to pursue the De Novo regulatory pathway,” said Bluejay’s Chief Executive Officer Neil Dey. “This confirms our belief that the Bluejay Symphony IL-6 Test has the potential to provide an innovative solution to the market. Bluejay continues to advance the Symphony IL-6 Test towards the company’s anticipated marketing application with the FDA, expected by year-end 2022.”
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About Bluejay Diagnostics Inc.
Bluejay Diagnostics is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient product for triage and monitoring of disease progression. Bluejay’s first product candidate, an IL-6 Test for sepsis triage, is designed to provide accurate, reliable results in approximately 20 minutes from “sample-to-result” to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.BlueJayDX.com.
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