IDx LLC, with assistance from Hogan Lovells, achieved a major grant of De Novo classification from the U.S. Food and Drug Administration for the novel artificial intelligence-based device IDx-DR. The product is the first device authorized for marketing that detects disease without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care.
April 18, 2018
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