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.
IDx-DR detect greater than a mild level of the eye disease diabetic retinopathy in adults. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause of vision impairment and blindness among working-age adults.
Due to its medical importance, the IDX-DR was granted Breakthrough Device Designation by the FDA.
The Hogan Lovells team was led by Janice Hogan (Picture) and Yarmela Pavlovic, with support from Tammi Huynh and Megana Sankaran.
Law Firms: Hogan Lovells;
Clients: IDx LLC;