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IRIS INTERNATIONAL, INC. (NASDAQ: IRIS), after extensive consultation with the US Food and Drug Administration (FDA), intends to resubmit its 510(k) for its NADiA(TM) PSA (Prostate Specific Antigen) ultra-sensitive diagnostic test with a prognostic claim. Following FDA advice, IRIS has already submitted a request for a Pre-Investigational Device Exemption meeting (Pre-IDE Meeting), an optional process through which the applicant consults with the FDA for the purpose of improving the quality...
- A murmuring sound; a rushing or whistling sound, like that of the wind; a deep sigh.
- A gentle breeze; a waft; a breath.
- Any rumor that engages general attention.
- A cant or whining mode of speaking, especially in preaching or praying; the chant or recitative characteristic of the old Presbyterians in Scotland.
- To make a rushing, whistling, or sighing sound; emit a hollow murmur; murmur or sigh like the wind.
- To breathe in or as in sleep.
- To utter in a whining or monotonous tone.