(24/7 Market News) VivoPower International PLC (NASDAQ: VVPR) is trading at $1.58, 29 cents higher (+22.48%), on 7,874,739 premarket shares traded, after closing at $1.29, up $0.22(+20.56%), on volume of 611,090 shares.
The medical diagnostics company, focused on improving patient outcomes using its Symphony System, 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. 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,” stated Neil Dey, Chief Executive Officer.
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