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Lumos Diagnostics sees stock plummet 65% on FDA rejection of Febridx 510(k)

July 15, 2022
By Tamra Sami
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
BioWorld MedTech Regulatory Drug resistance Infection Diagnostics Australia 510(k) FDA